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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: | NCT00309842 |
RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: total-body irradiation Procedure: umbilical cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen |
Estimated Enrollment: | 150 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, multicenter study.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Ages Eligible for Study: | up 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)
Disease in second or subsequent complete remission (CR)* OR in first CR* with high-risk features, as defined by 1 of the following:
Acute lymphocytic leukemia (ALL)
Disease in second or subsequent CR* OR in first CR* with high-risk features, as defined by 1 of the following:
Chronic myelogenous leukemia
MDS
Refractory anemia with severe pancytopenia or high-risk cytogenetics OR intermediate-2- or high-risk MDS by International Prognostic Scoring System, including any of the following:
Chronic lymphocytic leukemia
Prolymphocytic leukemia
Multiple myeloma, meeting 1 of the following criteria:
Completed initial therapy AND meets 1 of the following criteria:
Any of the following non-Hodgkin's lymphoma (NHL)
Patients with small lymphocytic lymphoma, marginal zone B-Cell lymphoma, or follicular lymphoma must have disease progression after ≥ 2 prior therapies
Patients with large cell NHL must meet both of the following criteria:
Patients with lymphoblastic lymphoma, Burkitt's lymphoma, or other high-grade NHL must meet the following criteria:
Must have HLA matched unrelated umbilical cord blood (UCB) donor available
May use 1 or 2 units of UCB
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 |
Study Chair: | 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: | CDR0000450160, UMN-2005LS043, UMN-BMT-MT2005-10, UMN-MT2005-10, UMN-0507M71475 |
Study First Received: | March 29, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00309842 |
Health Authority: | Unspecified |
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) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia |
childhood immunoblastic large cell lymphoma chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes meningeal chronic myelogenous leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue juvenile myelomonocytic leukemia stage I adult Burkitt lymphoma nodal marginal zone B-cell lymphoma contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma Waldenstrom macroglobulinemia noncontiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma stage I adult immunoblastic large cell lymphoma previously treated myelodysplastic syndromes |
Juvenile myelomonocytic leukemia Blast Crisis Cyclosporine Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Miconazole Lymphoma, Mantle-Cell Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Anemia, Refractory Hemorrhagic Disorders |
Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil 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 Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders |
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 |