Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Phase III Study of MDR Modulation With PSC-833 (NSC #648265) Followed by Immunotherapy With rIL-2 (NSC #373364) vs. No Further Therapy in Previously Untreated Patients With AML >60 Years
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs. Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells.
Status | Completed |
Enrollment | 640 |
Est. completion date | |
Est. primary completion date | August 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Unequivocal histologic diagnosis of AML, FAB classification (M0-M7), excluding M3 (acute promyelocytic leukemia); patients with a history of antecedent myelodysplasia remain eligible for treatment on this trial - No prior treatment for acute leukemia or myelodysplasia with four permissible exceptions: - Emergency leukapheresis; - Emergency treatment for hyperleukocytosis with hyroxyurea; - Cranial RT for CNS leukostasis (one dose only); - Growth factor/cytokine support. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer and Leukemia Group B | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival | Analyzed by intention to treat. | From second randomization to relapse or death, assessed up to 10 years | No |
Primary | Overall survival | Up to 10 years | No |
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