Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.

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

Details

• Lead Sponsor: III. Medizinische Klinik Mannheim
• Treatments: Busulfan; Cyclophosphamide; Cytarabine; Etoposide; Hydroxyurea; Idarubicin; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic myelogenous leukemia in chronic phase

• Previously untreated

• Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:

• Impaired health status with reduced exercise tolerance

• Spleen-related symptoms in cases of splenomegaly

• Weight loss greater than 10% in 6 months

• Fever greater than 38.5 degrees C on 5 consecutive days

• Clinically relevant bone pain

• Leukocytosis greater than 5,000/mm^3

• Thrombocytosis greater than 100,000/mm^3

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy

• No severe concurrent disease or other cause that would preclude study

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interferon

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified