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LeukemiaPhase 2NCT00003783

Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia

A Phase 2 study testing filgrastim, asparaginase and cyclophosphamide in people with Leukemia, run by Children's Oncology Group at 58 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and combining drugs in different ways may kill more cancer cells. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, asparaginase and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
58 sitesin 5 countries
Study dates
Mar 1999to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS: Newly diagnosed B-cell precursor acute lymphocytic leukemia No L3 morphology Very poor prognosis CNS 3 (blasts and WBC greater than 5 microliters) OR Must meet all of the following criteria: No simultaneous trisomy 4 and 10 DNA index no greater than 1.16 (if FISH 4 and 10 unsatisfactory) No TEL-AML1 [t(12;21)] Meets at least 1 of the following: Has MLL (11q23) and/or BCR-ABL [t(9;22)] WBC greater than 100,000/mm3 Age over 12 (boys) or 16 (girls) OR Boys Girls WBC 8 12 greater than 80,000/mm3 9 13 greater than 60,000/mm3 10 14 greater than 40,000/mm3 11 15 greater than 20,000/mm3 Concurrent registration on stratum 6 of POG-9400 before 11/15/1999 OR Concurrent registration on stratum 4 of POG-9900 after 11/15/1999 Concurrent registration on POG-9201, POG-9705, or POG-9806 unless ineligible

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Trial locations and contacts

58 sites in 5 countries.

58 sites in 5 countries

United States51 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • West Virginia University Medical School, Charleston Division

    Charleston, West Virginia, 25304

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • St. John's Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22046

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • James H. Quillen College of Medicine

    Johnson City, Tennessee, 37614-0622

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9162

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32803

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61602

  • Maine Children's Cancer Program

    Portland, Maine, 04101

  • Carilion Roanoke Community Hospital

    Roanoke, Virginia, 24029

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

Other trials in United States

Canada4 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

Other trials in Canada

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Switzerland1 site

  • Clinique de Pediatrie

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and combining drugs in different ways may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.

Read the detailed description

OBJECTIVES: I. Determine the feasibility of administering a new combination of agents during postinduction consolidation therapy in children with very high risk acute lymphocytic leukemia (VHR-ALL). II. Assess the tolerance of patients in remission of VHR-ALL for postconsolidation therapy with continuous intensification.

OUTLINE: Patients receive induction therapy on weeks 1-4. This consists of oral prednisone three times a day on days 1-28; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on days 8, 15, and 22; and asparaginase IM on days 2, 5, 8, 12, 15, and 19. Patients also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 and 3 disease also receive methotrexate IT on days 15 and 22. Patients who achieve M2 bone marrow on day 29 receive oral prednisone three times a day on days 29-42; vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36; and asparaginase IM on days 29, 32, 36, and 39. If bone marrow is M3 on day 29 or M2 or M3 on day 43, then patient is off study. Patients proceed to consolidation therapy on weeks 5-25. This consists of high dose methotrexate IV over 24 hours on weeks 6, 8, 16, and 18, followed by leucovorin calcium IV or orally every 6 hours for 5 doses; oral mercaptopurine on weeks 6-9 and 16-19; cytarabine IV over 6 hours followed by idarubicin IV over 15 minutes for 4 days; and filgrastim (G-CSF) subcutaneously (SQ) beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20. Patients receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23. Methotrexate IT is administered on weeks 6, 8, 13, 16, 18, and 23. Patients then proceed to continuous intensification therapy during weeks 26-61. Patients receive vincristine IV, daunorubicin IV, and methotrexate IT on day 1, and oral dexamethasone twice a day on days 1-7 on weeks 26, 32, 38, 44, 50, and 56. Patients also receive high dose cytarabine IV over 1 hour, every 12 hours, for 4 doses, followed by asparaginase IM 3 hours after the last dose of cytarabine, on weeks 27, 33, 39, 45, 51, and 57. Oral mercaptopurine and methotrexate IM are administered on day 1 during weeks 29, 31, 35, 37, 41, 43, 47, 49, 53, 55, 59, and 61. Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks 30, 36, 42, 48, 54, and 60. Patients then proceed to continuation therapy during weeks 62-126. Vincristine IV and cyclophosphamide IV are administered on weeks 62-65, 70-73, 78-81, 86-89, 94-97, 102-105, 110-113, and 118-121. Patients also receive oral dexamethasone twice a day for 7 days on weeks 62, 70, 78, 86, 94, 102, 110, and 118, and cytarabine IV on weeks 63, 65, 71, 73, 79, 81, 87, 89, 95, 97, 103, 105, 111, 113, 119, and 121. Oral mercaptopurine is administered daily during weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125 and methotrexate IM on weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125. Methotrexate IT is administered during weeks 62, 70, 78, 86, 94, 102, 110, and 118. Patients who are CNS 3 at diagnosis receive whole brain irradiation beginning at week 62 along with the first course of continuation therapy. These patients do not receive any methotrexate IT after week 62. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 12 months.

Conditions
Leukemia
Being tested
filgrastim, asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride
Keywords
untreated childhood acute lymphoblastic leukemia, L1 childhood acute lymphoblastic leukemia, L2 childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Also called G-CSF

  • asparaginaseDrug

    Also called E. coli, Elspar, NSC #109229

  • cyclophosphamideDrug

    Also called CTX, Cytoxan, NSC #026271

  • cytarabineDrug

    Also called cytosine arabinoside, Ara-C, Cytosar, NSC #063878

  • daunorubicin hydrochlorideDrug

    Also called daunomycin, DNR, Cerubidine, NSC #82151

  • dexamethasoneDrug

    Also called Decadron, NSC #034521

  • etoposideDrug

    Also called VP-16, VePesid, NSC #141540

  • idarubicinDrug

    Also called 4-demethoxydaunorubicin, Idamycin, NSC #256439

  • leucovorin calciumDrug

    Also called LCV, Wellcovorin, citrovorum factor, folinic acid

  • mercaptopurineDrug

    Also called 6-MP, Purinethol, NSC #000755

  • methotrexateDrug

    Also called MTX, amethopterin, NSC #000740, IND #4291

  • prednisoneDrug

    Also called Deltasone, Meticorten, Liquid Pred, NSC #010023

  • vincristine sulfateDrug

    Also called VCR, Oncovin, NSC #067574

  • radiation therapyRadiation

Study groups in NCT00003783
Study groupRoleWhat they receive
Complete Response and no CNS 3ExperimentalSee detailed description.
Receives: Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: idarubicin; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
Complete Response and CNS 3ExperimentalSee detailed description.
Receives: Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: idarubicin; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the feasibility of delivering a new combination of agents during a 20 week post-induction consolidation phase

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2004 (estimated)
  2. Study startMar 1999
  3. Primary completionNov 2002
  4. Study completionMar 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003783
Sponsor's protocol ID
9806
Other IDs
POG-9806, CDR0000066915
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
28 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, asparaginase and cyclophosphamide in people with Leukemia, run by Children's Oncology Group at 58 sites in 5 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada, Netherlands, Puerto Rico, Switzerland. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess the feasibility of delivering a new combination of agents during a 20 week post-induction consolidation phase (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003783.

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 28 Jul 2014.

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