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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: | NCT00305682 |
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. 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 II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation Radiation: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen |
Estimated Enrollment: | 320 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized study. Patients are stratified according to disease (acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia [CML] in first chronic phase and second chronic phase [CP2] after myeloid blast crisis vs acute lymphoblastic leukemia, CML CP2 post lymphoid blast crisis, lymphoblastic lymphoma, and Burkitt's lymphoma vs large cell B- and T-cell lymphomas and mantle cell lymphoma vs chronic lymphocytic leukemia, marginal zone B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and prolymphocytic leukemia vs Hodgkin's lymphoma and multiple myeloma).
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following advanced hematologic malignancies:
Acute leukemia in remission by morphology (< 5% blasts) OR cytogenetic relapse or persistent disease without morphologic relapse*
Acute myeloid leukemia, meeting 1 of the following criteria:
High-risk disease as evidenced by 1 of the following criteria:
Acute lymphoblastic leukemia/lymphoma, meeting 1 of the following criteria:
High-risk disease in first CR, as evidenced by 1 of the following:
Chronic myelogenous leukemia
Myelodysplastic syndromes (MDS)
Large cell lymphoma*, Hodgkin's lymphoma*, or multiple myeloma, meeting 1 of the following criteria:
Lymphoplasmacytic lymphoma, mantle cell lymphoma*, or prolymphocytic leukemia
Chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone B-cell lymphoma, or follicular lymphoma, meeting 1 of the following criteria:
Burkitt Lymphoma
Stable disease allowed provided the largest residual nodal mass is approximately < 5 cm
Must be ineligible for autologous transplantation due to one of the following criteria:
No evidence of progressive disease by imaging modalities or biopsy
Umbilical cord blood graft must match at 4-6 HLA-A, B, DRB1 antigens
PATIENT CHARACTERISTICS:
Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatrics)
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 |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Claudio G. Brunstein ) |
Study ID Numbers: | CDR0000456202, UMN-2005LS036, UMN-MT-2005-02, UMN-0507M70121 |
Study First Received: | March 21, 2006 |
Last Updated: | June 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00305682 History of Changes |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia relapsing chronic myelogenous leukemia refractory anemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory cytopenia with multilineage dysplasia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes adult acute myeloid leukemia in remission anaplastic large cell lymphoma |
childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent childhood large cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III childhood large cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV childhood large cell lymphoma recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma stage III adult Hodgkin lymphoma stage III childhood Hodgkin lymphoma |
Anti-Infective Agents Chronic Myelomonocytic Leukemia Cyclosporine Lymphoma, Mantle-Cell Mycophenolic Acid Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Refractory Anemia Acute Myelocytic Leukemia Preleukemia Leukemia, Prolymphocytic Anemia, Refractory Hemorrhagic Disorders Acute Myeloid Leukemia, Adult |
Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia |
Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Mycophenolic Acid Cyclosporins Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Mycophenolate mofetil Cardiovascular Diseases Dermatologic Agents Immunoproliferative Disorders |
Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Multiple Myeloma Neoplasms Fludarabine Lymphoma, Non-Hodgkin Antimetabolites Precancerous Conditions Immunologic Factors Blood Protein Disorders Antineoplastic Agents Paraproteinemias Cyclophosphamide Antibiotics, Antineoplastic |