Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous 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. Combining chemotherapy with bone marrow 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 various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German CML Study Group
• Treatments: Busulfan; Cytarabine; Hydroxyurea; Idarubicin; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed chronic myelogenous leukemia in chronic phase

• Philadelphia chromosome- or bcr/abl-positive

• Cytogenetic negativity (analyzed separately) allowed if at least 1 of the following criteria is met:

• Malaise with decreased performance status

• Weight loss of more than 10% within the past 6 months

• Fever more than 38.5 C for 5 consecutive days

• Symptomatic splenomegaly

• Leukocyte count greater than 50,000/mm^3

• Platelet count greater than 1,000,000/mm^3

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other medical condition that would reduce life expectancy

• No other uncontrolled malignancy

• Not pregnant

• No other contraindication to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interferon

Chemotherapy:

• No prior cytotoxic therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified