Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248430
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-11-03
Brief Title:
Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2010-09
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 Drugs used in chemotherapy such as melphalan work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing An autologous stem cell transplant using the patients stem cells may be able to replace blood-forming cells that were destroyed by chemotherapy Giving white blood cells from a donor may help the patients body destroy any remaining cancer cells Interleukin-2 may stimulate the white blood cells to kill cancer cells
PURPOSE This phase III trial is studying the side effects of donor white blood cell infusions and interleukin-2 and to see how well they work in treating patients who are undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer
PURPOSE This phase III trial is studying the side effects of donor white blood cell infusions and interleukin-2 and to see how well they work in treating patients who are undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and toxicity of haploidentical related donor lymphocyte infusions DLI and interleukin-2 in terms of acute graft-versus-host-disease graft failure and transplant-related mortality in patients with relapsed advanced lymphoid malignancies undergoing autologous stem cell transplantation
Secondary
Determine the extent degree and duration of donor chimerism in patients treated with this regimen
Determine preliminarily activity of haploidentical DLI as measured by complete response rate in these patients
OUTLINE This is a pilot study
Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous stem cell transplantation on day 0 Patients receive haploidentical related donor lymphocyte infusions DLI IV on days 1 5 and 10 and interleukin-2 IL-2 IV continuously on days 1-12
NOTE DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is present
After completion of study treatment patients are followed monthly for 3 months and then every 3-12 months thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the feasibility and toxicity of haploidentical related donor lymphocyte infusions DLI and interleukin-2 in terms of acute graft-versus-host-disease graft failure and transplant-related mortality in patients with relapsed advanced lymphoid malignancies undergoing autologous stem cell transplantation
Secondary
Determine the extent degree and duration of donor chimerism in patients treated with this regimen
Determine preliminarily activity of haploidentical DLI as measured by complete response rate in these patients
OUTLINE This is a pilot study
Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous stem cell transplantation on day 0 Patients receive haploidentical related donor lymphocyte infusions DLI IV on days 1 5 and 10 and interleukin-2 IL-2 IV continuously on days 1-12
NOTE DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is present
After completion of study treatment patients are followed monthly for 3 months and then every 3-12 months thereafter
PROJECTED ACCRUAL A total of 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 |
|---|---|---|---|
| CDR0000430694 | REGISTRY | PDQ | None |
| FHCRC-183800 | None | None | None |