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LeukemiaPhase 2NCT00003700

Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

A Phase 2 study testing G-CSF, asparaginase and cyclophosphamide in people with Leukemia, run by Alliance for Clinical Trials in Oncology at 50 sites in United States.

Completed

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

Official record
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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 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Leukemia
What is being tested?
G-CSF, asparaginase and cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
50 sitesUnited States
Study dates
Jan 1999to Jan 2010
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult
  1. Any other serious illnesses which would limit survival to <2 years, or psychiatric condition which would prevent compliance with treatment or informed consent.
  2. Uncontrolled or severe cardiovascular disease.
  3. History of pancreatitis or overt coagulopathy (prior cerebrovascular accident or hemorrhage, transient ischemic attack or deep venous thrombosis).
  4. Elevations in bilirubin, creatinine, or amylase that may suggest impaired hepatic, renal, or pancreatic function must be considered as potentially serious obstacles for safe tolerance of the therapy prescribed in this protocol.
  5. Prior use of the agents administered in this protocol for other non-malignant disease may reduce the likelihood of beneficial outcome, and should also be considered prior to enrolling patients.
  6. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
  7. Unequivocal histologic diagnosis of Acute Lymphoblastic leukemia (ALL), FAB L1-or L2 or Acute Undifferentiated Leukemia (AUL).
  8. Age ≥ 15 years
  9. Prior Treatment: No prior treatment for leukemia, with three permissible exceptions:
  10. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with hydroxyurea; iii. cranial RT for CNS leukostasis (one dose only).

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Cooper Cancer Institute

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13210

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Togus

    Togus, Maine, 04330

  • Lombardi Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation

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 may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the complete response rate and toxicity of escalating doses of daunorubicin in patients under 60 years old with untreated acute lymphoblastic leukemia (ALL).
  • Determine the complete response rate and toxicity of a constant dose of daunorubicin in patients at least 60 years old with untreated ALL.
  • Determine the toxicity of high dose cytarabine during postremission therapy in these patients.
  • Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and high-dose intravenous chemotherapy replace cranial irradiation.

OUTLINE:

  • Course I: Patients are assigned to 1 of 2 induction treatment groups based on age.
  • Group 1 (under age 60): Patients receive cyclophosphamide IV over 15-30 minutes on day 1, escalating doses of daunorubicin IV over 5-10 minutes on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-21, asparaginase intramuscularly on days 5, 8, 11, 15, 18, and 22, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing for at least 7 days and then until blood counts recover.
  • Group 2 (age 60 and over): Patients receive vincristine, asparaginase, cyclophosphamide, and G-CSF as in group 1, fixed dose daunorubicin IV over 5-10 minutes on days 1-3, and oral prednisone on days 1-7.

Patients are then evaluated for bone marrow cellularity on day 29. Those with M0, M1, or M2 cellularity proceed to course II. Patients with M3 cellularity may proceed to course II or be removed from study.

  • Course II (early intensification): Patients receive intrathecal methotrexate and cyclophosphamide IV over 15-30 minutes on day 1, cytarabine IV over 3 hours on days 1-3, and G-CSF SC beginning on day 4.

Bone marrow is again examined on day 29. Patients with M0 or M1 cellularity after course I and no sign of relapse after course II proceed to course III. Patients with M2 or M3 cellularity after course I must have M0 or M1 cellularity after course II to proceed to course III. Patients with M2 or M3 cellularity after course II are removed from study.

  • Course III: Patients receive intrathecal methotrexate, vincristine IV, and methotrexate IV over 3 hours on days 1, 8, and 15 and oral methotrexate every 6 hours for 4 doses beginning 6 hours after starting methotrexate IV on days 1, 2, 8, 9, 15, and 16. Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on days 2, 9, and 16 and oral leucovorin calcium beginning 12 hours after leucovorin calcium IV for at least 4 doses on days 3, 4, 10, 11, 17, and 18.

Patients must be off leucovorin calcium for a minimum of 3 days before beginning days 8 and 15 of treatment. Patients who maintain M0 or M1 cellularity on day 29 of course III continue therapy. Those with M2 or M3 cellularity after course III are removed from the study.

  • Course IV (Late intensification): Repeat course I.
  • Course V (Late intensification): Repeat course II.
  • Course VI (CNS intensification): Repeat course III.
  • Course VII (Prolonged maintenance): Patients receive oral mercaptopurine daily, vincristine IV once every 4 weeks, oral prednisone on days 1-5, and oral methotrexate on days 1, 8, 15, and 22. Courses repeat every 4 weeks for up to 18 months.

Patients with testicular disease receive gonadal radiotherapy anytime after course I. Chemotherapy is not halted during radiotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for 10 years.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study within 15 months.

Conditions
Leukemia
Being tested
G-CSF, asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride
Keywords
untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult 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.

  • G-CSFBiological

    Also called filgrastim

    Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC > 5,000 uL after nadir: 7 day minimum for Courses I \& IV

  • asparaginaseDrug

    6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I \& IV

  • cyclophosphamideDrug

    1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I \& IV (pts < 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II \& V

  • cytarabineDrug

    Also called ara-C

    2000 mg/sq m IV infusion over 3 hrs Days 1,2, \& 3: Courses II \& V

  • daunorubicin hydrochlorideDrug

    80mg/sq m (pts<60y/o)OR 60mg/sq m (pts =/>60y/o) IV infusion over 5-10 min Days 1,2,\& 3: Courses I \& IV

  • leucovorin calciumDrug

    Courses III \& VI:

    25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX <0.05 uM after ea IV dose

  • mercaptopurineDrug

    60mg/sq m/d PO every day Course VII

  • methotrexateDrug

    15mg intrathecal Day 1 Courses II \& V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, \& 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III \& VI.

  • prednisoneDrug

    60mg/sq m/day PO Days 1-21 (pts<60y/o) OR Days 1-7 (pts >/= 60y/o) Courses I \& IV and Days 1-5 of ea 4 cycle in Course VII

  • vincristine sulfateDrug

    2 mg total IV infusion Days 1,8,15,\& 22 Courses I \& IV and Days 1, 8, \& 15 Courses III \& VI, and Day 1 of ea 4 wk cycle in Course VII

  • AllopurinolDrug

    300mg PO q day Days 1-14 Course I

Study groups in NCT00003700
Study groupRoleWhat they receive
Daunorubicin, ara-C, & MTX TherapyExperimentaldaunorubicin during induction, increasing doses of cytarabine during consolidation followed by methotrexate in place of cranial irradiation for treatment of ALL
Receives: Biological: G-CSF; Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Drug: Allopurinol

What is being measured

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

  1. Complete Response

    Measured: 6 months post treatment

Secondary outcomes (2)

  1. Toxicity

    Measured: prior to ea tx and ea maintenance course

  2. CNS relapse rate

    Measured: before ea tx, q 3 mon for 1 yr, q 6 mon for 2 yrs, then yrly up to 10 yrs

Timeline

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

  1. First posted20 May 2004 (estimated)
  2. Study startJan 1999
  3. Primary completionFeb 2004
  4. Study completionJan 2010

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
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003700
Sponsor's protocol ID
CALGB-19802
Other IDs
U10CA031946, CDR0000066807
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Stock W, Yu D, Johnson J, et al.: Intensified Daunorubicin during induction and post-remission therapy of adult acute lymphoblastic leukemia (ALL): results of CALGB 19802. [Abstract] Blood 102 (11 Pt 1): A-1375, 2003.

  • Stock W, Dodge RK, Vardiman JW, et al.: Treatment of adult acute lymphoblastic leukemia (ALL): phase II trial of dose intensification of Daunorubicin and Cytarabine followed by high-dose Methotrexate and intrathecal Methotrexate in place of cranial irradiation (CALGB 19802). [Abstract] Blood 98 (11 Pt 1): A-2472, 2001.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G-CSF, asparaginase and cyclophosphamide in people with Leukemia, run by Alliance for Clinical Trials in Oncology at 50 sites in United States.

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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. 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?

Complete Response (time frame: 6 months post treatment). 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 NCT00003700, which also lists 2 linked publications.

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 6 Jul 2016.

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