Study:
S0521, A Randomized Trial of Maintenance Versus Observation for Patients With Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
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 05/27/10)
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Leukemia |
Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin |
Phase 3 |
Verified by
Southwest Oncology Group
January, 2013
Sponsored by: Southwest Oncology Group
Information provided by: Southwest Oncology Group
ClinicalTrials.gov identifier: NCT00492856
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Steven E. Coutre, MD., Study Chair