Overview

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Treatments:
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