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Sponsored by: |
Chimeric Therapies |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004255 |
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
Condition | Intervention | Phase |
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Graft Versus Host Disease Leukemia Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation Radiation: radiation therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to degree of HLA matching and disease (chronic vs acute).
Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes (yes vs no). Patients are randomized to one of two bone marrow transplantation arms.
All patients receive a conditioning regimen comprising fludarabine IV on day -6, cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0.
Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim (G-CSF) is administered subcutaneously from day 0 until blood counts recover.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.
Ages Eligible for Study: | 12 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
AML in first complete remission with one of the following adverse features:
ALL in first complete remission with poor risk cytogenetics such as
Myelodysplastic syndromes
Unrelated bone marrow donor available
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
University of California San Diego Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
United States, Colorado | |
Presbyterian-St Luke's Medical Center | |
Denver, Colorado, United States, 80218 | |
United States, District of Columbia | |
Lombardi Cancer Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Shands Hospital and Clinics, University of Florida | |
Gainesville, Florida, United States, 32610-100277 | |
United States, Indiana | |
Indiana Blood and Marrow Transplantation | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kentucky | |
James Graham Brown Cancer Center | |
Louisville, Kentucky, United States, 40202 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, New York | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14642 | |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73190 | |
United States, Oregon | |
Oregon Cancer Center | |
Portland, Oregon, United States, 97201-3098 | |
United States, Pennsylvania | |
Hahnemann University Hospital | |
Philadelphia, Pennsylvania, United States, 19102-1192 | |
United States, Texas | |
South Texas Cancer Institute | |
San Antonio, Texas, United States, 78229 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0037 |
Study Chair: | James N. Lowder, MD | Chimeric Therapies |
Study ID Numbers: | CDR0000067502, CHIMERIC-HM01, WSU-10-02-99-M01-FB |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004255 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission |
childhood acute lymphoblastic leukemia in remission refractory anemia with excess blasts refractory anemia with excess blasts in transformation secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes graft versus host disease childhood myelodysplastic syndromes |
Anti-Inflammatory Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Tacrolimus Hormones Refractory Anemia Graft Versus Host Disease Acute Myelocytic Leukemia Preleukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Neoplasm Metastasis Methylprednisolone Hemisuccinate |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Hematologic Diseases Leukemia, Myeloid Glucocorticoids Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Antimetabolites Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precancerous Conditions Immunologic Factors Prednisolone acetate Leukemia, Myeloid, Chronic-Phase |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Cyclophosphamide Tacrolimus Hormones |
Neuroprotective Agents Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome Alkylating Agents Methylprednisolone Hemisuccinate Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Gastrointestinal Agents |