Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004878
Status:
WITHDRAWN
Last Update Posted:
2020-07-31
First Post:
2000-03-07
Brief Title:
Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Study to Determine the Safety and Efficacy of Using CD8-High Density Microparticles CD8-HDM to Deplete CD8 Cells From Donor Lymphocyte Infusion in Order to Reduce Graft-versus-Host Disease GvHD Without Compromising an Anti-Leukemia Effect in Patients With Chronic Myeloid Leukemia Given HLA-Identical Sibling Peripheral Blood Stem Cell Transplants After Non-Myeloablative Conditioning
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study never opened
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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
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
Detailed Description:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1672 | None | None | None |
| UCLA-9905097 | None | None | None |
| CCT-C99-101 | None | None | None |