drugset / Trial / NCT00025402

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

NCT00025402

Phase 3 Unknown 1000 enrolled III. Medizinische Klinik Mannheim
RandomizedTreatment

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.

Timeline

Start
1997-07
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Subcutaneous
Subject Etoposide Small molecule Intravenous
Subject Hydroxyurea Other / unclassified Intravenous
Subject Idarubicin Small molecule Intravenous
Subject interferon alfa-2b Protein / enzyme biologic Subcutaneous
Background Busulfan Small molecule Oral
Background Cyclophosphamide Other / unclassified
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications