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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00617929 |
RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.
Condition | Intervention | Phase |
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Cancer |
Biological: anti-thymocyte globulin Biological: filgrastim Biological: rituximab Drug: clofarabine Drug: cyclosporine Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation |
Estimated Enrollment: | 28 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Must be in primary or secondary graft failure after hematopoietic stem cell transplantation, defined as a > 50% loss of donor chimerism* from previous maximum or less than 25% donor beyond day +42 with pancytopenia and no evidence of relapse
Patients with any diagnosis, type of donor, hematopoietic cell graft, or prior conditioning regimen allowed
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Principal Investigator: | Jakub Tolar, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Jakub Tolar ) |
Study ID Numbers: | CDR0000587062, UMN-2007LS072, UMN-MT2007-07 |
Study First Received: | February 15, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00617929 History of Changes |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis |
chronic myelomonocytic leukemia chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative disease, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma 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 immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
Anti-Infective Agents Chronic Myelomonocytic Leukemia Blast Crisis Cyclosporine Lymphoma, Mantle-Cell Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Wilms' Tumor Mycophenolate mofetil |
Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Rhabdomyosarcoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Testicular Cancer Rituximab Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Hairy Cell Leukemia Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia Breast Neoplasms |
Anti-Infective Agents Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclosporins Antifungal Agents Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Mycophenolate mofetil Lymphoma Dermatologic Agents Clofarabine |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Lymphatic Diseases Neoplasms Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |