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S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Details
| Lead sponsor | SWOG Cancer Research Network |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 105 |
| Start date | Fri Jun 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed May 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Leukemia
Interventions
- mercaptopurine
- methotrexate
- tretinoin
Countries
United States