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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00653289 |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's 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 tacrolimus and methotrexate after transplant may stop this from happening. Studying samples of blood from patients with cancer or other diseases in the laboratory may help doctors learn more about changes in T cells in patients undergoing donor stem cell transplant.
PURPOSE: This clinical trial is studying T cells in patients undergoing donor stem cell transplant for hematologic cancer or other diseases.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cytarabine Procedure: allogeneic hematopoietic stem cell transplantation Procedure: laboratory biomarker analysis Procedure: total-body irradiation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | T-REGULATORY CELL KINETICS POST TRANSPLANT FOR PATIENTS UNDERGOING MATCHED SIBLING STEM CELL TRANSPLANTATION |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2026 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *Patients with testicular or CNS disease or other focal disease may receive additional irradiation.
Blood samples are collected periodically during study to measure changes in the number and function of CD4+CD25+ Foxp3 regulatory T-cells at specific time points after transplantation and to correlate these changes with GVHD.
After completion of study therapy, patients are followed periodically.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Unlikely to be cured by standard chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Marlen Dinu 832-824-4881 | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Marlen Dinu 832-824-4881 |
Study Chair: | Robert Krance, MD | Baylor College of Medicine |
Study ID Numbers: | CDR0000582426, BCM-H-19164 |
Study First Received: | April 3, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00653289 |
Health Authority: | Unspecified |
adult acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia adult acute myeloid leukemia in remission recurrent adult acute myeloid leukemia 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) secondary acute myeloid leukemia refractory chronic lymphocytic leukemia |
relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia chronic myelomonocytic leukemia juvenile myelomonocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
Juvenile myelomonocytic leukemia Blast Crisis Sezary syndrome Chronic myelogenous leukemia Chronic myelomonocytic leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Mycoses Preleukemia Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Acute myeloid leukemia, adult |
Hodgkin Disease 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 Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase |
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 Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |