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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: | NCT00602693 |
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal 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 cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory cells 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 cyclosporine and mycophenolate mofetil, and removing the T cells from the donor cells before transplant, may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory cells after an umbilical cord blood transplant in treating patients with advanced hematologic cancer or other disorder.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation Procedure: umbilical cord blood transplantation Procedure: umbilical cord blood-derived lymphocyte therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of Infusion of Umbilical Cord Blood (UCB) Derived CD25+CD4+ T-Regulatory (Treg) Cells After Nonmyeloablative Cord Blood Transplantation |
Estimated Enrollment: | 46 |
Study Start Date: | July 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of umbilical cord blood (UCB)-derived T-regulatory (Treg) cells. Patients receive nonmyeloablative UCB transplantation and post-transplant immunosuppression as in protocol UMN-2005LS036 (without antithymocyte globulin during conditioning regimen).
After completion of study treatment, patients are followed at day 180, 360, and 720.
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Eligible for and co-enrolled on protocol UMN-2005LS036, for treatment of any of the following advanced hematologic malignancies:
Acute leukemia in remission by morphology (< 5% blasts in bone marrow with cellularity ≥ 15%), including any of the following:
Acute myeloid leukemia (AML) in second or greater complete remission (CR) OR high-risk AML in first CR (CR1), meeting 1 of the following criteria:
Acute lymphoblastic leukemia/lymphoma in second or greater CR OR high-risk disease in CR1, meeting 1 of the following criteria:
Chronic myelogenous leukemia
Myelodysplastic syndromes (MDS)
Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma meeting 1 of the following criteria:
Chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after at least 2 prior therapies
Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia
Not scheduled to receive antithymocyte globulin during conditioning regimen on protocol UMN-2005LS036, due to 1 of the following prior therapies:
Must be ineligible for autologous transplantation due to any of the following:
Patients with stable disease are eligible provided the largest residual nodal mass is < 5 cm (approximately)
No evidence of progressive disease by imaging modalities or biopsy
Must have two or three partially HLA-matched umbilical cord blood (UCB) units available
Minimum cryopreserved cell dose of each unit is 1.5 x 10^7 nucleated cells/kilogram recipient body weight
PATIENT CHARACTERISTICS:
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: | Claudio G. Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota |
Principal Investigator: | Margaret L. MacMillan, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000579096, UMN-2007LS022, UMN-MT2006-01, UMN-0701M00303, UMN-12559, UMN-6220-04 |
Study First Received: | January 10, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00602693 |
Health Authority: | Unspecified |
polycythemia vera essential thrombocythemia chronic neutrophilic leukemia chronic idiopathic myelofibrosis chronic eosinophilic leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
prolymphocytic leukemia refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage III grade 2 follicular lymphoma |
Cyclosporine Chronic myelogenous leukemia Refractory anemia Hodgkin lymphoma, adult Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic |
Myelodysplastic syndromes Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Myelodysplastic myeloproliferative disease Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |