Overview

Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Busulfan
Cytarabine
Etoposide
Hydroxyurea
Idarubicin
Interferon-alpha
Interferons
Criteria
DISEASE CHARACTERISTICS: Newly diagnosed chronic myelogenous leukemia in chronic phase
Philadelphia chromosome and/or BCR/ABL positive Initial diagnosis within 6 months of
randomization No clinical or laboratory evidence of acceleration or blastic disease No
contraindication to peripheral blood cell stem cell collection prior to treatment

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No major organ impairment Not pregnant Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa Chemotherapy: Prior
hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery:
Not specified