Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Completed · Phase 3
Conditions studied: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT00003190
- Run by
- National Cancer Institute (NCI)
- People needed
- 640
- Starts
- 1998-01-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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