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Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
This study is currently recruiting patients.
Sponsored by: | Robert H. Lurie Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome.
Condition | Treatment or Intervention | Phase |
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adult acute monoblastic and acute monocytic leukemia adult acute myeloid leukemia atypical chronic myeloid leukemia childhood acute myeloid leukemia and other myeloid malignancies Chronic Myelomonocytic Leukemia myelodysplastic and myeloproliferative disease |
Drug: busulfan Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: high-dose chemotherapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: Bone Marrow Diseases; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed By Allogeneic Bone Marrow Transplantation in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
OBJECTIVES:
OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0.
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0.
All patients receive prophylaxis for graft versus host disease.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 16 Years - 60 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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