Lymphoma Clinical Trial
Official title:
A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone ("ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol
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: This randomized phase III trial is studying two different chemotherapy regimens and
comparing them to see how well they work in treating adults with acute lymphoblastic
leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
Status | Completed |
Enrollment | 170 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Stanford Cancer Center at Stanford University Medical Center | Stanford | California |
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Remission (CR) | complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. | 2 years | No |
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