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| Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00305682 |
Purpose
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 |
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation Procedure: umbilical cord blood transplantation |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Anemia Ataxia Telangiectasia Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| ChemIDplus related topics: | Cyclophosphamide Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride |
| 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 |
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).
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Eligibility
| 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
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:
Contacts and Locations| 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 | |||||
| Masonic Cancer Center, University of Minnesota |
| National Cancer Institute (NCI) |
| Principal Investigator: | Claudio G. Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000456202, UMN-2005LS036, UMN-MT-2005-02, UMN-0507M70121 |
| First Received: | March 21, 2006 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00305682 |
| Health Authority: | Unspecified |
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