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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00208962 |
This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer) in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer drugs or radiation treatments.
Condition | Intervention | Phase |
---|---|---|
Hematologic Diseases |
Procedure: chemotherapy and blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Cell Therapy for Adults With Hematologic Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | September 1998 |
Estimated Study Completion Date: | September 2020 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Procedure: chemotherapy and blood stem cell transplantation
A combination of conventional dose chemotherapy, G-CSF mobilized HLA-identical related allogeneic PBSC transplant, and post transplant infusions of donor leukocytes.
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This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer) in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer drugs or radiation treatments. Intensive treatment with high doses of chemotherapy followed by a bone marrow transplant (BMT) from an HLA-(tissue-type) matched related donor would provide the best chance for cure of this leukemia or lymphoma. However, the success of BMT from relatives is limited in patients who are older than 50 years and/or have organ dysfunction by substantial complications due to the high dose chemotherapy related toxicity, graft-versus- host disease (GVHD), and relapse. Patients eligible for this study have an HLA matched sibling, but a BMT from the sibling would carry a high risk for severe side effects due to the patient's age, and/or organ dysfunction.
Researchers are evaluating a new treatment for adult patients with leukemia and lymphoma which involves regular dose chemotherapy and blood stem cell transplantation from an HLA-matched relative, with injections of donor immune cells (a type of white blood cells) given if you later relapse. In this study, the safety and feasibility of this treatment strategy are being investigated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Amelia Langston, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Amelia Langston, MD ) |
Study ID Numbers: | 0466-1998 |
Study First Received: | September 13, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00208962 |
Health Authority: | United States: Institutional Review Board |
Hematologic Diseases |
Hematologic Neoplasms Hematologic Diseases |
Neoplasms Neoplasms by Site |