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Bone Marrow Transplantation Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer
This study is currently recruiting patients.
Sponsored by: | Fox Chase 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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining bone marrow transplantation from an unrelated donor with cyclophosphamide and total-body irradiation in treating patients who have hematologic cancer.
Condition | Treatment or Intervention | Phase |
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Acute Lymphocytic Leukemia Acute Myeloid Leukemia atypical chronic myeloid leukemia Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia myelodysplastic and myeloproliferative disease |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Drug: immune globulin Drug: methotrexate Drug: sargramostim Drug: tacrolimus 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: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: graft versus host disease prophylaxis/therapy Procedure: high-dose chemotherapy Procedure: non-specific immune-modulator therapy Procedure: radiation therapy Procedure: supportive care/therapy |
Phase II |
MedlinePlus related topics: 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 Unrelated Bone Marrow Transplantation with Cyclophosphamide and Total-Body Irradiation in Patients With Hematologic Malignancies/Disorders
OBJECTIVES:
OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure.
All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin.
Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.
Eligibility
Ages Eligible for Study: 17 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
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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