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Home > "C" Clinical Trials Conditions > Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma  Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,adult acute lymphoblastic leukemia,adult lymphoblastic lymphoma,blastic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia. PURPOSE: Randomizedphase III trial to compare the effectiveness of two chemotherapy regimens in treating adults who have acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
Details: OBJECTIVES: - Compare the incidence of complete remission (CR) following induction with the ALL-2 regimen (cytarabine and high-dose mitoxantrone) vs the L-20 regimen (vincristine and prednisone) in previously untreated adult patients with acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, and lymphoid blast crisis chronic myelogenous leukemia. - Compare the time to CR, length of hospital stay, efficacy of treatment in Philadelphia chromosome-positive ALL, and the proportion of patients achieving durable (greater than 5 years) remission in each treatment regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating institution and antecedent lymphoid blast crisis of chronic myelogenous leukemia (yes vs no). Patients are randomized to one of two treatment arms. Arm I: - Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover. - At 7-14 days following induction therapy, patients receive consolidation therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-30 and methotrexate intrathecally on days 8, 15, 22, and 29. - At 2-3 weeks following the last dose of vincristine, patients receive an additional course of consolidation therapy consisting of cyclophosphamide IV on day 1 and GM-CSF subcutaneously beginning on day 3 and continuing until blood counts recover. - At 3-4 weeks following the second consolidation course, patients receive a third course of consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with etoposide IV over 1 hour on days 1-3 and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover. - Following recovery from the third consolidation course, patients receive a fourth consolidation course consisting of pegaspargase IV or intramuscularly (IM) on day 1. - Following recovery from consolidation therapy patients receive 2 sequences of maintenance therapy with sequence one consisting of vincristine IV on days 1 and 8, oral prednisone 2-3 times daily on days 1-8, doxorubicin IV on day 15, oral mercaptopurine 2-3 times daily on days 36-64, oral methotrexate on days 39, 46, 53, and 60, dactinomycin IV on day 85, and methotrexate intrathecally on days 36 and 43. - At 2 weeks following sequence one of maintenance therapy, patients receive sequence two consisting of the same regimen as in the first sequence with the addition of cyclophosphamide IV and carmustine IV on day 15. - Patients with CNS involvement receive whole brain radiotherapy in addition to chemotherapy regimens. Arm II: - Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover. - At approximately 3 weeks following induction therapy, patients receive consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-5, with daunorubicin IV on days 1-3 and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover. - At 6-8 weeks following the first course of consolidation therapy, patients receive a second consolidation course consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with methotrexate IV on days 1-4 and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover. - At 6-8 weeks following the second course of consolidation therapy, patients receive a third consolidation course consisting of pegaspargase IV or IM on day 1. - At 3-4 weeks following the third course of consolidation therapy, patients receive a fourth consolidation course consisting of cyclophosphamide IV on day 1. - At 3 weeks following the completion of consolidation therapy, patients receive the same maintenance regimen as in Arm I. Treatment continues in patients achieving complete response. Patients in both arms receive alternating sequences of maintenance therapy over 2 years. PROJECTED ACCRUAL: A total of 154 patients will be accrued for this study within approximately 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of one of the following malignancies: - Acute lymphoblastic leukemia (ALL) of B- or T-cell lineage - Philadelphia chromosome-positive ALL eligible - Lymphoblastic lymphoma - Chronic myelogenous leukemia in lymphoid blast crisis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 20-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 mg/dL - Glucocorticoids for higher bilirubin allowed prior to entry, at principal investigator's discretion Renal: - Creatinine no greater than 2.0 mg/dL - Glucocorticoids or renal radiotherapy for higher creatinine allowed prior to entry, at principal investigator's discretion Cardiovascular: - Left ventricular ejection fraction at least 50% Other: - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy Chemotherapy - No prior chemotherapy Endocrine therapy - No prior endocrine therapy Radiotherapy - No prior radiotherapy Surgery - No prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkWeiss, Study Chair, Memorial Sloan-Kettering Cancer Center
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Leonard Heffner 404-778-4189
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Mark Weiss 212-639-5827
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Matt Kalaycio 216-444-3705
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Joseph Moore 919-684-3377
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Gary Schiller 310-825-5513
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5750
United States
Recruiting Steven Coutre 650-725-4040
New York Medical College *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Karen Seiter 914-493-7514
Additional Information:
Study ID Numbers: CDR0000064730; MSKCC-96015A1,NCI-V96-0881
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002766
Other Adult Acute Lymphoblastic Leukemia Studies:
1. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
2. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
3. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
4. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
5. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Related Studies:
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Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
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