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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00719888 |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, 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 after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well umbilical cord blood transplant given together with cyclophosphamide, fludarabine, and total-body irradiation works in treating patients with hematologic disease.
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: | 60 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed at 6 months, 1 year, and 2 years.
Ages Eligible for Study: | 1 Year to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hematological malignancy, meeting any of the following criteria:
Acute Myeloid Leukemia (AML)
Acute lymphoblastic leukemia
Chronic myelogenous leukemia, excluding refractory blast crisis
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, or follicular lymphoma that has progressed after at least two different prior therapies
Large cell NHL > CR2 and > PR2
Multiple myeloma beyond PR2
UCB graft matched at 4-6 HLA-A, -B, -DRB1 antigens with the recipient
PATIENT CHARACTERISTICS:
None of the following conditions or diseases:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Colleen Delaney, MD, MSC 206-667-1385 sdelaney@fhcrc.org |
Principal Investigator: | Colleen Delaney, MD, MSC | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Colleen Delaney ) |
Study ID Numbers: | CDR0000597644, FHCRC-2010.00 |
Study First Received: | July 19, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00719888 |
Health Authority: | Unspecified |
adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission childhood 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) accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic idiopathic myelofibrosis |
secondary acute myeloid leukemia childhood myelodysplastic syndromes previously treated myelodysplastic syndromes contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma stage I adult lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma Burkitt lymphoma contiguous stage II adult Burkitt lymphoma |
Blast Crisis Cyclosporine Chronic myelogenous 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 Blood Coagulation Disorders Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma |
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 |