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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049504 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving chemotherapy, tacrolimus, mycophenolate mofetil, and radiation therapy together with allogeneic bone marrow transplant works in treating patients with hematologic cancer.
Condition | Intervention | Phase |
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Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation |
Estimated Enrollment: | 50 |
Study Start Date: | January 2002 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 4 and continuing until blood counts recover.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 15-30 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following hematologic malignancies:
Acute myeloid leukemia (AML) in first complete remission (CR) with the following high-risk cytogenetics:
High-risk acute lymphoblastic leukemia with less than 5% marrow blasts
First CR with the following high-risk cytogenetics:
Stage II or III multiple myeloma, meeting 1 of the following:
Chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or Hodgkin's lymphoma
Related 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, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Paul V. O'Donnell, MD, PhD 206-667-1968 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Study Chair: | Paul V. O'Donnell, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Paul V. O'Donnell ) |
Study ID Numbers: | CDR0000258112, FHCRC-1667.00, NCI-H02-0098 |
Study First Received: | November 12, 2002 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00049504 |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission refractory chronic lymphocytic leukemia relapsing chronic myelogenous leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia de novo myelodysplastic syndromes noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma |
noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent childhood large cell lymphoma |
Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Mycophenolic Acid Lymphoma, small cleaved-cell, diffuse Tacrolimus Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Acute myeloid leukemia, adult |
Hodgkin Disease Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Myelodysplastic myeloproliferative disease |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |