Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096161
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2004-11-09
Brief Title:
Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Pentostatin and Donor Lymphocyte Infusion for Low Donor T-cell Chimerism After Hematopoietic Cell Transplantation - A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant Giving pentostatin and an infusion of the donors T cells donor lymphocyte infusion after a donor stem cell transplant may stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving pentostatin before donor lymphocyte infusion may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and efficacy of the combined use of pentostatin and donor lymphocyte infusion DLI in patients with low or falling donor T-cell chimerism to prevent graft rejection after transplantation both from matched related donors MRDs or unrelated donors URDs
SECONDARY OBJECTIVES
I To determine the incidence of graft-versus-host disease GvHD infections and disease response if persistent disease is present
OUTLINE This is a dose-escalation study of donor lymphocyte infusion
GROUP I Patients receive pentostatin intravenously IV over 20-30 minutes on day -2 and DLI over 15-30 minutes on day 0 Treatment may repeat once beginning with an escalated or same cluster of differentiation CD3-dose at least 4 weeks if persistent donor T-cells are documented no GvHD has developed and the chimerism status worsens or if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart
GROUP II initiated if patients in group I do not achieve sustained engraftment and improved chimerism Patients receive treatment as in group I Patients also receive cyclosporine orally PO twice daily BID on days -3 to 56 and mycophenolate mofetil PO once daily QD on days 0 to 27 Treatment continues in the absence of GvHD
After completion of study treatment patients are followed up every 6 months for 2 years and then annually thereafter
I To assess the safety and efficacy of the combined use of pentostatin and donor lymphocyte infusion DLI in patients with low or falling donor T-cell chimerism to prevent graft rejection after transplantation both from matched related donors MRDs or unrelated donors URDs
SECONDARY OBJECTIVES
I To determine the incidence of graft-versus-host disease GvHD infections and disease response if persistent disease is present
OUTLINE This is a dose-escalation study of donor lymphocyte infusion
GROUP I Patients receive pentostatin intravenously IV over 20-30 minutes on day -2 and DLI over 15-30 minutes on day 0 Treatment may repeat once beginning with an escalated or same cluster of differentiation CD3-dose at least 4 weeks if persistent donor T-cells are documented no GvHD has developed and the chimerism status worsens or if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart
GROUP II initiated if patients in group I do not achieve sustained engraftment and improved chimerism Patients receive treatment as in group I Patients also receive cyclosporine orally PO twice daily BID on days -3 to 56 and mycophenolate mofetil PO once daily QD on days 0 to 27 Treatment continues in the absence of GvHD
After completion of study treatment patients are followed up every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-00230 | REGISTRY | None | None |
| 182500 | OTHER | None | None |
| P01CA078902 | NIH | None | None |