Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
NCT ID: NCT00003700
Last Updated: 2016-07-06
Study Results
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Basic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
1999-01-31
2010-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daunorubicin, ara-C, & MTX Therapy
daunorubicin during induction, increasing doses of cytarabine during consolidation followed by methotrexate in place of cranial irradiation for treatment of ALL
G-CSF
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
asparaginase
6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I \& IV
cyclophosphamide
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
cytarabine
2000 mg/sq m IV infusion over 3 hrs Days 1,2, \& 3: Courses II \& V
daunorubicin hydrochloride
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 calcium
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
mercaptopurine
60mg/sq m/d PO every day Course VII
methotrexate
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.
prednisone
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 sulfate
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
Allopurinol
300mg PO q day Days 1-14 Course I
Interventions
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G-CSF
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
asparaginase
6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I \& IV
cyclophosphamide
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
cytarabine
2000 mg/sq m IV infusion over 3 hrs Days 1,2, \& 3: Courses II \& V
daunorubicin hydrochloride
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 calcium
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
mercaptopurine
60mg/sq m/d PO every day Course VII
methotrexate
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.
prednisone
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 sulfate
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
Allopurinol
300mg PO q day Days 1-14 Course I
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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:
i. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with hydroxyurea; iii. cranial RT for CNS leukostasis (one dose only).
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Wendy Stock, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cooper Cancer Institute
Camden, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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CDR0000066807
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-19802
Identifier Type: -
Identifier Source: org_study_id
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