Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Baylor College of Medicine |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00622297 |
RATIONALE: Giving chemotherapy, a monoclonal antibody, and total body irradiation before a donor stem cell 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 certain 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 infusions of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory with immunotoxin after the transplant may keep this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells when given together with a donor stem cell transplant after chemotherapy, monoclonal antibody therapy, and total body irradiation in treating patients with leukemia or other hematologic disorders.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition |
Biological: RFT5-dgA immunotoxin Biological: alemtuzumab Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cytarabine Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A PHASE I TRIAL EVALUATING THE USE OF RFT5-DGA TO DEPLETE ALLOREACTIVE CELLS PRIOR TO HAPLOIDENTICAL STEM CELL TRANSPLANTATION |
Estimated Enrollment: | 24 |
Study Start Date: | July 2000 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of one of the following:
Acute lymphoblastic leukemia meeting the following criteria:
Stage III or IV high-grade non-Hodgkin lymphoma meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Methodist Hospital | |
Houston, Texas, United States, 77030 | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
Houston, Texas, United States, 77030-2399 |
Study Chair: | Malcolm K. Brenner, MD, PhD | Baylor College of Medicine |
Study ID Numbers: | CDR0000582429, BCM-H-9033 |
Study First Received: | February 22, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00622297 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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) recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia childhood myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes hemophagocytic lymphohistiocytosis |
childhood immunoblastic large cell lymphoma recurrent adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma Burkitt lymphoma recurrent adult Burkitt lymphoma |
Anti-Infective Agents Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Mycoses Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Alemtuzumab Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphohistiocytosis, Hemophagocytic |
Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Waldenstrom Macroglobulinemia B-cell Lymphomas Hemophagocytic Lymphohistiocytosis Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Antimetabolites Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Immunologic Factors Precancerous Conditions Lymphoma, Follicular |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome Alemtuzumab |
Lymphoma, Large-Cell, Immunoblastic Alkylating Agents Lymphoma Cytarabine Neoplasms by Histologic Type Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Immunotoxins |