|
Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia Clinical research trials and Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia  Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
For Condition: accelerated phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,Graft Versus Host Disease,chronic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this from happening. PURPOSE: Randomized phase II trial to study the effectiveness of donor lymphocytes to prevent graft-versus-host disease in patients who are undergoing peripheral stem cell transplantation for chronic myeloid leukemia.
Details: OBJECTIVES: I. Compare the incidence of acute graft versus host disease (GVHD) grades II-IV and extensive chronic GVHD in chronic myeloid leukemia patients treated with purged donor lymphocyte infusion (DLI) processed with CD8 high density microparticles (HDM) vs unpurged DLI following nonmyeloablative, HLA identical sibling peripheral blood stem cell transplantation. II. Compare the rates of complete cytogenetic, clinical, and hematologic remission and mortality and GVHD in patients treated with these regimens. III. Determine the efficacy of CD8 HDM in depleting greater than 95% of CD8+ cells in donor lymphocytes. IV. Compare the safety and toxicity of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by age (under 60 vs 60 and over) and center. Allogeneic peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells on days 5-8. Nonmyeloablative conditioning: Patients receive fludarabine IV over 30 minutes and cytarabine IV over 4 hours (beginning 4 hours after the start of fludarabine infusion) on days -6 to -3 and idarubicin IV over 1-5 minutes on days -6 to -4. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day -2 and continues until blood counts recover. Graft versus host disease prevention: Beginning on day -2, patients receive tacrolimus IV continuously until oral dosing is tolerated. Patients receive tacrolimus in combination with methotrexate on days 1, 3, and 6 after completion of transplantation. Beginning 12 weeks after completion of transplantation, oral tacrolimus is tapered and stopped over 4 weeks. Transplantation: Allogeneic PBSC are infused on day 0. At 4 months posttransplantation, patients with residual Ph+ cells by cytogenetics or FISH OR hematologic or clinical evidence of chronic myeloid leukemia AND without symptomatic chronic graft versus host disease requiring immunosuppressive therapy are randomized to 1 of 2 treatment arms: Arm I: Lymphocytes harvested from the original PBSC donor are processed with the CD8 high density microparticle device to remove all or most CD8+ cells. Patients receive CD8+ cell depleted donor lymphocyte infusion (DLI) IV over 15-30 minutes on the same day of collection. Arm II: Lymphocytes are harvested from the original PBSC donor. Patients receive undepleted DLI IV over 15-30 minutes on the same day of collection. Patients are followed at days 30, 60, 100, and 180, and then periodically through year 5. PROJECTED ACCRUAL: A maximum of 110 patients (55 per arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 50 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven chronic myeloid leukemia (CML) in first chronic phase or with cytogenetic but not hematologic evidence of acceleration (clonal evolution) - Availability of 6 antigen (A, B, and DR loci) HLA identical sibling donor - Eligible for randomization to donor lymphocyte infusion (DLI) if: Residual Ph+ cells by cytogenetics or FISH or hematologic or clinical evidence of CML AND No graft versus host disease requiring immunosuppressive therapy within the past 2 weeks AND Evidence of donor hematopoiesis after completion of transplantation - Ineligible for randomization to DLI if: Blast transformation of CML OR Prior interferon alfa for relapse after completion of transplantation --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No concurrent hematopoietic growth factors other than filgrastim (G-CSF); No other biologic therapy (e.g., interferon alfa) for 6 months after completion of study therapy - Chemotherapy: No other chemotherapy for 6 months after completion of study therapy; Concurrent hydroxyurea allowed for CML relapse - Endocrine therapy: Concurrent methylprednisolone allowed if grade II or worse GVHD develops - Radiotherapy: No radiotherapy for 6 months after completion of study therapy - Surgery: Not specified --Patient Characteristics-- - Age: 50 to 70 - Performance status: Zubrod 0-2 - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 3 mg/dL - Renal: Creatinine less than 2 mg/dL - Cardiovascular: Cardiac ejection fraction greater than 40% - Pulmonary: DLCO greater than 45% predicted - Other: No active infection; Not pregnant; Negative pregnancy test; No hypersensitivity to nickel; No hypersensitivity to mouse proteins; Human antimouse antibody positivity allowed if no allergic history; HIV negative; HTLV antibody negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchiller, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067538; UCLA-9905097,NCI-G00-1672,CCT-C99-101
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004878
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
2. Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease
3. Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
4. Radiolabeled Monoclonal Antibody Therapy Combined With Total-body Irradiation, Allogeneic Peripheral Stem Cell Transplantation, and Immunosuppression Therapy in Treating Older Patients Who Have Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
5. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
|
|
|
|
|
|
|
|
