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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: | NCT00343798 |
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide and fludarabine, before a donor umbilical cord blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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 before or after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of fludarabine, cyclophosphamide, and total-body irradiation followed by umbilical cord blood stem cell transplant in treating patients with hematologic cancer and other diseases.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: filgrastim Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: umbilical cord blood transplantation Radiation: total-body irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies |
Estimated Enrollment: | 15 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, open-label, nonrandomized, pilot study.
Myeloablative conditioning regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV over 1 hour on days -7 and
PROJECTED ACCRUAL: A total of 15 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 in complete remission (CR), as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of ≥ 15%
Meets 1 of the following criteria:
In first complete remission (CR1) with any of the following high-risk features:
No acute leukemia in relapse, as defined by ≥ 5% marrow blasts by morphology
Acute lymphoblastic leukemia in CR, as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of ≥ 15%
Meets 1 of the following criteria:
In CR1 with any of the following high-risk features:
Chronic myelogenous leukemia
Patients in blast crisis (BC) are eligible provided they received therapy and achieved accelerated or chronic phase
MDS
Meets 1 of the following criteria:
Lymphoblastic lymphoma, Burkitt's lymphoma, or other high-grade non-Hodgkin's lymphoma (NHL)
Meets 1 of the following stage criteria:
Chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, or follicular lymphoma
Mantle cell lymphoma or prolymphocytic leukemia
Large cell NHL
In > CR2 or > second PR (PR2)
Multiple myeloma
Umbilical cord blood (UCB) units available
Two UCB units must be 0-2 HLA-A, -B, and - DRB1 mismatched with the recipient and to each other
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior autologous or allogeneic stem cell transplantation with a myeloablative preparative regimen
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 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Colleen Delaney, MD, MSC | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000482298, FHCRC-2044.00, AMGEN-200981 |
Study First Received: | June 22, 2006 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00343798 History of Changes |
Health Authority: | Unspecified |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia in remission 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) childhood acute myeloid leukemia in remission secondary acute myeloid leukemia accelerated phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia chronic idiopathic myelofibrosis refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia |
de novo myelodysplastic syndromes secondary myelodysplastic syndromes contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma stage I adult lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma recurrent adult Burkitt lymphoma |
Cyclosporine Miconazole Lymphoma, Mantle-Cell Mycophenolic Acid Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Refractory Anemia Acute Erythroblastic Leukemia 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 B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia Leukemia, Erythroblastic, Acute B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase |
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 |