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Sponsored by: |
Blood and Marrow Transplant Group of Georgia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00827099 |
RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin 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 |
Biological: anti-thymocyte globulin Drug: fludarabine phosphate Drug: melphalan Drug: mycophenolate mofetil Drug: tacrolimus Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies |
Estimated Enrollment: | 21 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD. After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hematologic malignancy for which a reduced-intensity allogeneic stem cell transplantation is deemed clinically appropriate, including any of the following:
Chronic myelogenous leukemia, meeting one of the following criteria:
Acute myelogenous leukemia, meeting one of the following criteria:
Acute lymphoblastic leukemia, meeting one of the following criteria:
Myelodysplastic syndromes, meeting the following criteria:
Chronic myelomonocytic leukemia
Myeloid metaplasia with myelofibrosis with poor-risk features, meeting one of the following criteria:
Chronic lymphocytic leukemia/prolymphocytic leukemia, meeting all of the following criteria:
Low-grade B-cell non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma, follicular center [grade 1 or 2] lymphoma, or marginal zone lymphoma), meeting all of the following criteria:
Intermediate-grade B-cell or T-cell NHL or mantle cell NHL, meeting all of the following criteria:
Hodgkin lymphoma, meeting all of the following criteria:
Multiple myeloma, meeting one of the following criteria:
Has two umbilical cord blood units available that are matched at ≥ 4/6 HLA A, B, and DRB1 with the patient and with each other (HLA C and DQ will not be used in the match strategy)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Georgia | |
Blood and Marrow Transplant Group of Georgia | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Scott R. Solomon, MD 404-255-1930 |
Principal Investigator: | Scott R. Solomon, MD | Blood and Marrow Transplant Group of Georgia |
Responsible Party: | Blood and Marrow Transplant Group of Georgia ( Scott R. Solomon ) |
Study ID Numbers: | CDR0000632453, BMTGG-NSH-801 |
Study First Received: | January 21, 2009 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00827099 History of Changes |
Health Authority: | Unspecified |
accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult 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) blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia prolymphocytic leukemia recurrent adult T-cell leukemia/lymphoma relapsing chronic myelogenous leukemia secondary acute myeloid leukemia |
refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Chronic Myelomonocytic Leukemia Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Tacrolimus Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis |
Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Leukemia, T-Cell |
Antimetabolites Melphalan Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Tacrolimus Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders |
Pathologic Processes Therapeutic Uses Syndrome Mycophenolate mofetil Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases |