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CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation Clinical research trials and CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation  CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
For Condition: Multiple Myeloma,Non Hodgkin's Lymphoma,Hodgkin's Disease,Chronic Myelogenous Leukemia,Chronic Lymphocytic Leukemia
Status: Terminated
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and HD. Secondary Objectives: To evaluate safety and treatment related mortality after CD8 depleted DLI. To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. To evaluate the incidence and timing of pancytopenia following DLI. To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
Details: Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and HD. Secondary Objectives: To evaluate safety and treatment related mortality after CD8 depleted DLI. To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. To evaluate the incidence and timing of pancytopenia following DLI. To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (>20% donor cell within three months of study entry) - Expected survival >4 weeks - CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation a. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart. b. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate >10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation. - CML patients with accelerated phase or blast crisis following allogeneic transplantation - Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or: a. MM- patients with a rising M-protein is detectable at 180 days post-transplant b. NHL – patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant c. CLL, NHL or HD – patients with clear cut evidence of tumor growth at any time post-transplant are eligible - Patients undergoing an HLA –identical or 5/6 antigen match transplant from a related or unrelated donor - Patient’s original donor must be available for lymphocyte donation - There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (<16 mg/d) without evidence of active GVHD are also eligible. - Patients must have a Zubrod PS<2 (see appendix 7), Cr<2.5, bilirubin <3, and transaminases (SGPT, SGOT) <4x normal - Patient must be able to sign informed consent
Total Enrollment: 90
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID00-335;
Study Start Date: May 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038818
Other Chronic Lymphocytic Leukemia Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
2. Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers
3. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
4. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
5. Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
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