Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, imatinib mesylate may stop the growth of cancer cells by blocking the enzymes needed for cancer cell growth. 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 which treatment regimen is most effective in treating chronic phase chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying imatinib mesylate with or without interferon alfa or cytarabine to see how well it works compared with interferon alfa followed by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.

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

Details

• Lead Sponsor: Heidelberg University; III. Medizinische Klinik Mannheim
• Treatments: Cytarabine; Hydroxyurea; Imatinib Mesylate; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed chronic phase chronic myelogenous leukemia (CML)

• bcr-abl positive

• No blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood

• Availability of a HLA-identical sibling or unrelated donor

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No second malignancy requiring therapy

• No evidence of disease-related symptoms or extramedullary disease (including hepatosplenomegaly)

• No serious diseases that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interferon

Chemotherapy

• No prior chemotherapy other than hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• Prior anagrelide allowed

• No participation in another clinical trial