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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: | NCT00376519 |
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory cells before the transplant may help increase this effect. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of umbilical cord blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in treating patients with high-risk leukemia or other hematologic diseases.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation Procedure: umbilical cord blood transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Umbilical Cord Blood Transplant With Co-Infusion of T Regulatory Cells |
Estimated Enrollment: | 24 |
Study Start Date: | May 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of CD4- and CD25-positive umbilical cord blood (UCB)-derived T-regulatory cells (Treg).
NOTE: *If the patient has acute GVHD requiring systemic therapy, MMF may be stopped 7 days after GVHD is controlled (e.g., resolution of skin rash, vomiting, and diarrhea).
Cohorts of 3-6 patients receive escalating doses of UCB-derived Treg cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience nonhematologic dose-limiting toxicity within 48 hours of Treg cell infusion. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML)
In second or greater CR OR in high-risk first CR (CR1) as evidenced by any of the following:
Acute lymphocytic leukemia (ALL) meeting 1 of the following criteria:
In high-risk CR1 as evidenced by either of the following:
Chronic myelogenous leukemia (CML)
Myelodysplasia
Meets 1 of the following criteria:
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma
Lymphoplasmacytic lymphoma, mantle-cell lymphoma, or prolymphocytic leukemia
Large cell non-Hodgkin lymphoma (NHL)
Lymphoblastic lymphoma, Burkitt lymphoma, or other high-grade NHL
Multiple myeloma
Must have 3 units of partially HLA-matched umbilical cord blood (UCB) available
One UCB unit identified as T-regulatory cells source
Two UCB units identified as the hematopoietic stem cell (HSC) source
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Claudio G. Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000491190, UMN-2005LS011, UMN-0502M67473, UMN-MT2005-01 |
Study First Received: | September 13, 2006 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00376519 |
Health Authority: | United States: Federal Government |
graft versus host disease adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission secondary acute myeloid leukemia 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) refractory anemia with excess blasts in transformation refractory anemia with excess blasts de novo myelodysplastic syndromes secondary myelodysplastic syndromes previously treated myelodysplastic syndromes chronic phase chronic myelogenous leukemia |
relapsing chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia refractory anemia blastic phase chronic myelogenous leukemia prolymphocytic leukemia stage IV adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage I adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma noncontiguous stage II grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma |
Blast Crisis Cyclosporine Chronic myelogenous leukemia Refractory anemia Graft versus host disease Miconazole Lymphoma, Mantle-Cell Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Anemia, Refractory Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell |
Mycophenolate mofetil Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Acute myeloid leukemia, adult Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid |
Antimetabolites Anti-Infective Agents 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 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 |