Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104975
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2005-03-03
Brief Title:
Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Reduced Intensity Conditioning Regimen for Haplo-identical Family Donor Stem Cell Transplants for Hematologic Malignancies With Delayed Add-back of Non-alloreactive T Cells
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells graft-versus-tumor effect Giving an infusion of the donors T cells that have been treated in the laboratory after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving tacrolimus before and after transplant may stop this from happening
PURPOSE This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer
PURPOSE This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Determine the feasibility and efficacy of a reduced-intensity conditioning regimen comprising alemtuzumab fludarabine melphalan and thiotepa followed by allogeneic peripheral blood stem cell transplantation PBSCT in patients with hematologic malignancies
Determine the toxicity of this regimen in these patients
Determine the safety of LMB-2 immunotoxin-treated selectively-depleted donor T cells administered after allogeneic PBSCT in these patients
OUTLINE This is a dose-escalation study of LMB-2 immunotoxin-treated selectively-depleted donor T cells
T cell preparation Patients and donors undergo apheresis to obtain peripheral blood mononuclear cells PBMCs which are expanded in culture Patients PBMCs are irradiated and mixed with donor PBMCs LMB-2 immunotoxin is added to the PBMCs in order to selectively deplete T cells from the donor PBMCs
Conditioning Patients receive alemtuzumab IV over 2 hours on days -9 to -5 fludarabine IV over 30 minutes on days -8 to -5 melphalan IV over 15-20 minutes on day -4 and thiotepa IV on days -3 to -2
Immunosuppression Patients receive tacrolimus IV continuously on days -10 to 1
Allogeneic peripheral blood stem cell PBSC transplantation Patients undergo allogeneic PBSC transplantation on day 0
LMB-2 immunotoxin-treated selectively-depleted donor T cells Patients receive LMB-2 immunotoxin-treated selectively-depleted donor T cells IV over 30-60 minutes on approximately day 28
Cohorts of 3-6 patients receive escalating dose of LMB-2 immunotoxin-treated selectively-depleted donor T cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting-toxicity
After completion of study treatment patients are followed weekly for 100 days post-transplantation and then periodically for survival
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study
Determine the feasibility and efficacy of a reduced-intensity conditioning regimen comprising alemtuzumab fludarabine melphalan and thiotepa followed by allogeneic peripheral blood stem cell transplantation PBSCT in patients with hematologic malignancies
Determine the toxicity of this regimen in these patients
Determine the safety of LMB-2 immunotoxin-treated selectively-depleted donor T cells administered after allogeneic PBSCT in these patients
OUTLINE This is a dose-escalation study of LMB-2 immunotoxin-treated selectively-depleted donor T cells
T cell preparation Patients and donors undergo apheresis to obtain peripheral blood mononuclear cells PBMCs which are expanded in culture Patients PBMCs are irradiated and mixed with donor PBMCs LMB-2 immunotoxin is added to the PBMCs in order to selectively deplete T cells from the donor PBMCs
Conditioning Patients receive alemtuzumab IV over 2 hours on days -9 to -5 fludarabine IV over 30 minutes on days -8 to -5 melphalan IV over 15-20 minutes on day -4 and thiotepa IV on days -3 to -2
Immunosuppression Patients receive tacrolimus IV continuously on days -10 to 1
Allogeneic peripheral blood stem cell PBSC transplantation Patients undergo allogeneic PBSC transplantation on day 0
LMB-2 immunotoxin-treated selectively-depleted donor T cells Patients receive LMB-2 immunotoxin-treated selectively-depleted donor T cells IV over 30-60 minutes on approximately day 28
Cohorts of 3-6 patients receive escalating dose of LMB-2 immunotoxin-treated selectively-depleted donor T cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting-toxicity
After completion of study treatment patients are followed weekly for 100 days post-transplantation and then periodically for survival
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study
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 |
|---|---|---|---|
| YALE-25971 | None | None | None |
| NCI-6765 | None | None | None |