LeukemiaPhase 1/2NCT00372619
Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
A Phase 1/2 study testing clofarabine, cytarabine and methotrexate in people with Leukemia, run by Children's Oncology Group at 79 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- clofarabine, cytarabine and methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 79 sitesin 2 countries
- Study dates
- Mar 2007to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia (AML) with ≥ 5% blasts in the bone marrow (M2/M3 bone marrow) with or without extramedullary disease
- Acute lymphoblastic leukemia (ALL) with > 25% blasts in the bone marrow (M3 bone marrow) with or without extramedullary disease
- Acute leukemia of ambiguous lineage with ≥ 5% blasts in the bone marrow (M2/M3 bone marrow) with or without extramedullary disease
- Disease must have relapsed after or be refractory to prior induction therapy
- Patients with AML or acute leukemia of ambiguous lineage must be in first relapse OR refractory to first induction therapy with ≤ 1 attempt at remission induction
- Patients with AML who enroll on the phase I portion of the study must have received prior mitoxantrone hydrochloride and cytarabine for newly diagnosed AML (phase I closed to accrual as of 09/16/09)
- Patients with ALL must be in second or third relapse (≤ 3 prior induction regimens) OR refractory to reinduction in first relapse
- Patients with ALL refractory to first induction therapy are not eligible
- No acute promyelocytic leukemia
- No CNS 3 involvement (i.e., WBC ≥ 5/μL in the cerebrospinal fluid with blasts present on cytospin)
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age) OR ECOG PS 0-2
- Life expectancy ≥ 8 weeks
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
- Direct bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT < 2.5 times ULN (unless it is related to leukemic involvement)
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 45% by gated radionuclide study
- No evidence of dyspnea at rest or exercise intolerance
- Pulse oximetry > 94% at room air
- Amylase ≤ 1.5 times ULN
- Lipase < 1.5 times ULN
- No active, uncontrolled grade 3 or 4 infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No known hepatitis B or C infection or history of cirrhosis
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy*
- At least 14 days since prior cytotoxic therapy (except hydroxyurea and intrathecal chemotherapy)*
- At least 7 days since prior biologic agent*
- At least 14 days since prior monoclonal antibody therapy*
- No more than 1 prior autologous or allogeneic hematopoietic stem cell transplantation
- No evidence of active graft-vs-host disease
- At least 4 months since transplantation
- No other concurrent chemotherapy or immunomodulating agents
- No other concurrent investigational therapy NOTE: *Patients who relapse during ALL maintenance therapy do not require a waiting period.
Trial locations and contacts
79 sites in 2 countries.
79 sites in 2 countries
United States74 sites
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, 71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0286
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322
Children's Hospital Colorado Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-5000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, 29203
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Dayton Children's - Dayton
Dayton, Ohio, 45404-1815
Southern California Permanente Medical Group
Downey, California, 90027
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, 33901
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Greenville Hospital Cancer Center
Greenville, South Carolina, 29605
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Penn State Children's Hospital
Hershey, Pennsylvania, 17033-0850
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Baylor University Medical Center - Houston
Houston, Texas, 77030-2399
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216-4505
Nemours Children's Clinic
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Missouri, 64108
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89109-2306
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, 90801
Kosair Children's Hospital
Louisville, Kentucky, 40232
Children's Hospital Central California
Madera, California, 93638-8762
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Overlook Hospital
Morristown, New Jersey, 07962
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507-1971
Children's Hospital of Orange County
Orange, California, 92868
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-9786
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, 97227
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, 24014
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Primary Children's Medical Center
Salt Lake City, Utah, 84113-1100
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
Rady Children's Hospital - San Diego
San Diego, California, 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99220-2555
Simmons Cooper Cancer Institute
Springfield, Illinois, 62794-9677
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, 33607
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, 01655
Canada5 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination With Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
Read the detailed description
OBJECTIVES:
Primary
- To define the overall response rate (complete remission or remission without platelet recovery) in young patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) treated with clofarabine in combination with cytarabine.
Secondary
- To determine the safety profile and tolerability of clofarabine when given in combination with cytarabine in patients with and without prior stem cell transplantation.
- To identify apoptosis specific genes that are important in mediating response to clofarabine and cytarabine.
- To quantitate the level of human equilibrative nucleoside transporter proteins (hENT1 and hENT2) and human concentrative nucleoside transporter proteins (hCNT2 and hCNT3) in blasts of these patients.
- To determine gene expression profiles at study entry and at time of relapse in order to isolate profiles that may predict response and also to complement apoptosis specific protein arrays.
- To perform serial measurements of minimal residual disease (MRD) to provide an objective determination of the effectiveness of this treatment regimen and to correlate with post remission events (relapse, death).
- To perform FLT3/ITD analysis to help determine the prevalence and clinical significance of this somatic mutation in patients with relapsed AML.
OUTLINE: This is a multicenter, phase I, dose-escalation study of clofarabine followed by a phase II study. Patients are stratified according to disease (acute lymphoblastic leukemia [ALL] vs acute myeloid leukemia [AML]). (Phase I closed to accrual as of 09/16/09)
- Intrathecal CNS prophylaxis (all patients with ALL and at physician's discretion for patients with AML or acute leukemia of ambiguous lineage): Patients receive intrathecal (IT) cytarabine on day 0 of the first course of induction therapy. Patients also receive IT methotrexate on day 1 of the second course of induction therapy and on day 1 of all courses of maintenance therapy.
- Induction therapy:
- Course 1: Patients receive cytarabine IV over 2 hours and clofarabine IV over 2 hours on days 1-5. Patients with ≥ 5% blasts (i.e., M2 or M3 bone marrow) at days 14-21 proceed immediately to course 2 of induction therapy. Patients with < 5% blasts (i.e., M1 bone marrow) may proceed to course 2 of induction therapy at blood count recovery or at day 42.
- Course 2: Patients receive clofarabine IV over 2 hours followed by cytarabine IV over 2 hours on days 1-5. After the second course of induction therapy, patients with M2 or M3 bone marrow at days 14-21 are removed from the study. Patients with M1 bone marrow proceed to maintenance therapy 14-42 days after the initiation of course 2.
- Maintenance therapy: Patients receive clofarabine and cytarabine as in induction therapy. Treatment repeats every 14-42 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and bone marrow sample collection periodically for correlative laboratory studies.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- clofarabine, cytarabine, methotrexate, laboratory biomarker analysis
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, acute undifferentiated leukemia, adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), childhood acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), childhood acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), childhood acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), childhood acute erythroleukemia (M6), adult acute megakaryoblastic leukemia (M7), childhood acute megakaryocytic leukemia (M7)
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofarabineDrug
Also called Cl-F-Ara-A, CAFdA, 2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-9H-purin-6-amine, Clolar
Given IV for 5 days
cytarabineDrug
Also called Cytosine arabinoside, Ara-C, Cytosar, NSC #063878
Given IV
methotrexateDrug
Also called MTX, amethopterin, Trexall, NSC #000740
Given intrathecally or IT age based dosage
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine 40 mg/m² to assess feasibility in ALL patients. | Experimental | Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 40 mg/m² to assess feasibility in AML patients. | Experimental | Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 52 mg/m² to assess feasibility in ALL patients. | Experimental | Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 52 mg/m² to assess efficacy in ALL patients. | Experimental | Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 52 mg/m² to assess feasibility in AML patients. | Experimental | Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 52 mg/m² to assess efficacy in AML patients | Experimental | Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
| Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt | Experimental | Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Receives: Drug: clofarabine; Drug: cytarabine; Drug: methotrexate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)
Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).
Overall response for AML patients: (CR + CRp), defined as:
CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week)).
Measured: 2 cycles or up to 84 days
Secondary outcomes (2)
Safety and Tolerability as Measured by CTCAE v3.0
Number of participants with at least one grade 3 or higher adverse event during therapy.
Measured: End of therapy
Correlate the Expression of Apoptosis Specific Genes
Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).
Measured: End of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMar 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bassem I. Razzouk, MD, Study chair, St. Vincent Indianapolis HospitalTodd Cooper, DO, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372619
- Sponsor's protocol ID
- AAML0523
- Other IDs
- CDR0000494654, NCI-2009-00319, COG-AAML0523
- Status last verified
- Feb 2017
- First submitted
- 6 Sep 2006
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination With Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia
- ClinicalTrials.gov ID
- NCT00372619
- Acronym / sponsor ID
- AAML0523
- Conditions
- Leukemia
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, acute undifferentiated leukemia, adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Posted 3 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
Detailed description
OBJECTIVES:
Primary
- To define the overall response rate (complete remission or remission without platelet recovery) in young patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) treated with clofarabine in combination with cytarabine.
Secondary
- To determine the safety profile and tolerability of clofarabine when given in combination with cytarabine in patients with and without prior stem cell transplantation.
- To identify apoptosis specific genes that are important in mediating response to clofarabine and cytarabine.
- To quantitate the level of human equilibrative nucleoside transporter proteins (hENT1 and hENT2) and human concentrative nucleoside transporter proteins (hCNT2 and hCNT3) in blasts of these patients.
- To determine gene expression profiles at study entry and at time of relapse in order to isolate profiles that may predict response and also to complement apoptosis specific protein arrays.
- To perform serial measurements of minimal residual disease (MRD) to provide an objective determination of the effectiveness of this treatment regimen and to correlate with post remission events (relapse, death).
- To perform FLT3/ITD analysis to help determine the prevalence and clinical significance of this somatic mutation in patients with relapsed AML.
OUTLINE: This is a multicenter, phase I, dose-escalation study of clofarabine followed by a phase II study. Patients are stratified according to disease (acute lymphoblastic leukemia [ALL] vs acute myeloid leukemia [AML]). (Phase I closed to accrual as of 09/16/09)
- Intrathecal CNS prophylaxis (all patients with ALL and at physician's discretion for patients with AML or acute leukemia of ambiguous lineage): Patients receive intrathecal (IT) cytarabine on day 0 of the first course of induction therapy. Patients also receive IT methotrexate on day 1 of the second course of induction therapy and on day 1 of all courses of maintenance therapy.
- Induction therapy:
- Course 1: Patients receive cytarabine IV over 2 hours and clofarabine IV over 2 hours on days 1-5. Patients with ≥ 5% blasts (i.e., M2 or M3 bone marrow) at days 14-21 proceed immediately to course 2 of induction therapy. Patients with < 5% blasts (i.e., M1 bone marrow) may proceed to course 2 of induction therapy at blood count recovery or at day 42.
- Course 2: Patients receive clofarabine IV over 2 hours followed by cytarabine IV over 2 hours on days 1-5. After the second course of induction therapy, patients with M2 or M3 bone marrow at days 14-21 are removed from the study. Patients with M1 bone marrow proceed to maintenance therapy 14-42 days after the initiation of course 2.
- Maintenance therapy: Patients receive clofarabine and cytarabine as in induction therapy. Treatment repeats every 14-42 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and bone marrow sample collection periodically for correlative laboratory studies.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Clofarabine 40 mg/m² to assess feasibility in ALL patients. | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 40 mg/m² to assess feasibility in AML patients. | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 52 mg/m² to assess feasibility in ALL patients. | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 52 mg/m² to assess efficacy in ALL patients. | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 52 mg/m² to assess feasibility in AML patients. | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 52 mg/m² to assess efficacy in AML patients | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
| Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt | Experimental | Drug: clofarabine, Drug: cytarabine, Drug: methotrexate, Other: laboratory biomarker analysisClofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clofarabineAlso: Cl-F-Ara-A, CAFdA, 2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-9H-purin-6-amine, ClolarGiven IV for 5 days | Drug | Clofarabine 40 mg/m² to assess feasibility in ALL patients., Clofarabine 40 mg/m² to assess feasibility in AML patients., Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt, Clofarabine 52 mg/m² to assess efficacy in ALL patients., Clofarabine 52 mg/m² to assess efficacy in AML patients, Clofarabine 52 mg/m² to assess feasibility in ALL patients., Clofarabine 52 mg/m² to assess feasibility in AML patients. |
| cytarabineAlso: Cytosine arabinoside, Ara-C, Cytosar, NSC #063878Given IV | Drug | Clofarabine 40 mg/m² to assess feasibility in ALL patients., Clofarabine 40 mg/m² to assess feasibility in AML patients., Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt, Clofarabine 52 mg/m² to assess efficacy in ALL patients., Clofarabine 52 mg/m² to assess efficacy in AML patients, Clofarabine 52 mg/m² to assess feasibility in ALL patients., Clofarabine 52 mg/m² to assess feasibility in AML patients. |
| methotrexateAlso: MTX, amethopterin, Trexall, NSC #000740Given intrathecally or IT age based dosage | Drug | Clofarabine 40 mg/m² to assess feasibility in ALL patients., Clofarabine 40 mg/m² to assess feasibility in AML patients., Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt, Clofarabine 52 mg/m² to assess efficacy in ALL patients., Clofarabine 52 mg/m² to assess efficacy in AML patients, Clofarabine 52 mg/m² to assess feasibility in ALL patients., Clofarabine 52 mg/m² to assess feasibility in AML patients. |
| laboratory biomarker analysis | Other | Clofarabine 40 mg/m² to assess feasibility in ALL patients., Clofarabine 40 mg/m² to assess feasibility in AML patients., Clofarabine 52 mg/m² to assess efficacy - ambiguous lineage pt, Clofarabine 52 mg/m² to assess efficacy in ALL patients., Clofarabine 52 mg/m² to assess efficacy in AML patients, Clofarabine 52 mg/m² to assess feasibility in ALL patients., Clofarabine 52 mg/m² to assess feasibility in AML patients. |
Primary outcome
Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)
Time frame: 2 cycles or up to 84 days
Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL). Overall response for AML patients: (CR + CRp), defined as: CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week)).
2 secondary outcomes
Safety and Tolerability as Measured by CTCAE v3.0
Time frame: End of therapy
Correlate the Expression of Apoptosis Specific Genes
Time frame: End of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem I. Razzouk, MD study chair
St. Vincent Indianapolis Hospital
Todd Cooper, DO study chair
University of Alabama at Birmingham
79 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing clofarabine, cytarabine and methotrexate in people with Leukemia, run by Children's Oncology Group at 79 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (CR for ALL Patients), (CR + CRp for AML Patients) (time frame: 2 cycles or up to 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.