Overview
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTCCollaborator:
Gruppo Italiano Malattie EMatologiche dell'AdultoTreatments:
6-Mercaptopurine
Busulfan
Cyclophosphamide
Cytarabine
Etoposide
Idarubicin
Mercaptopurine
Methotrexate
Mitoxantrone
Thioguanine
Tretinoin
Criteria
DISEASE CHARACTERISTICS:- Newly diagnosed acute promyelocytic leukemia
- Must have promyelocyte-retinoic acid receptor alpha transcript at disease presentation
PATIENT CHARACTERISTICS:
Age:
- 16 to 74
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
Renal:
- Creatinine no greater than 2.5 mg/dL
Cardiovascular:
- No cardiac contraindication to anthracycline chemotherapy
Other:
- No active serious infection not controlled by antibiotics
- No severe concurrent psychiatric disease
- No other malignancy except basal cell carcinoma
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- Prior corticosteroids for leukemia allowed
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No prior antileukemic therapy