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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00296023 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: anti-thymocyte globulin Drug: busulfan Drug: filgrastim Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Drug: therapeutic allogeneic lymphocytes Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies |
Estimated Enrollment: | 30 |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a high-risk indolent hematologic malignancy meeting the following criteria:
Chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
Non-Hodgkin's lymphoma (NHL) meeting 1 of the following criteria:
Low-grade NHL meeting 1 of the following criteria:
In first or subsequent remission with adverse International Prognostic Index (IPI) prognostic features, as defined by the presence of ≥ 3 of the following:
Intermediate- or high-grade NHL meeting 1 of the following criteria:
Waldenstrom's macroglobulinemia meeting 1 of the following criteria:
Multiple myeloma meeting 1 of the following criteria:
Myeloproliferative disorders, including any of the following:
Prolymphocytic leukemia meeting 1 of the following criteria:
Mantle cell lymphoma meeting 1 of the following criteria:
Hodgkin's lymphoma meeting the following criteria:
In second or subsequent remission
Myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
In CR or partial remission or stabilization of disease after standard chemotherapy
Meets 1 of the following criteria:
Younger patients with any of the following comorbidities:
Sibling or related donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Alta Bates Comprehensive Cancer Center | |
Berkeley, California, United States, 94704 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0324 |
Principal Investigator: | Thomas G. Martin, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Principal Investigator: | Willis Navarro, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Principal Investigator: | Charles A. Linker, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000463724, UCSF-98251, UCSF-9805, UCSF-H9996-15837-06 |
Study First Received: | February 23, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00296023 |
Health Authority: | United States: Federal Government |
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma noncontiguous stage II marginal zone lymphoma stage III marginal zone lymphoma |
stage IV marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma noncontiguous stage II adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma |
Polycythemia Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Tacrolimus Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Anemia, Refractory Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell |
Hemorrhagic thrombocythemia Neoplasm Metastasis Methotrexate Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Hodgkin Disease Essential thrombocytosis Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders |
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 Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Syndrome Abortifacient Agents Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |