Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472329
Status:
UNKNOWN
Last Update Posted:
2014-06-30
First Post:
2007-05-10
Brief Title:
Fludarabine and 400 CGY Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor Hematopoietic Stem Cell Transplants Who Have Rejected Their First Allogeneic Stem Cell Transplant
Sponsor:
Colorado Blood Cancer Institute
Organization:
Colorado Blood Cancer Institute
Study Overview
Official Title:
Fludarabine and 400 CGY Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor Hematopoietic Stem Cell Transplants Who Have Rejected Their First Allogeneic Stem Cell Transplant
Status:
UNKNOWN
Status Verified Date:
2014-06
Last Known Status:
RECRUITING
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:
Major Objectives A To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients who have rejected 5 T Cell Chimerism a previous allogeneic hematopoietic stem cell graft by using an allogeneic SCT from an HLA-Identical or non-identical family donor or unrelated donors with fludarabine 150mgm2 and TBI 400cGy with post-transplantation immunosuppression utilizing tacrolimus and MMF
B To evaluate the incidence of transplant related mortality
Minor Objectives A To evaluate the incidence of acute and chronic GVHD after second allogeneic HCT utilizing TacMMF with peripheral blood stem cells from matched or mis-matched allogeneic donors
B To evaluate disease responses and survival after second allogeneic SCT C To evaluate the need for DLI after second transplant for either disease control or persistent mixed chimerism
B To evaluate the incidence of transplant related mortality
Minor Objectives A To evaluate the incidence of acute and chronic GVHD after second allogeneic HCT utilizing TacMMF with peripheral blood stem cells from matched or mis-matched allogeneic donors
B To evaluate disease responses and survival after second allogeneic SCT C To evaluate the need for DLI after second transplant for either disease control or persistent mixed chimerism
Detailed Description:
This protocol will evaluate the use of Fludarabine 150mgm2 with TBI 400cGy as pre-transplant conditioning for a second allogeneic stem cell transplant after initial graft rejection Preliminary data suggest that the combination of FluTBI at the proposed doses is safer and more effective than prior second transplantation regimens published to date As we perform more non-myeloablative transplantations we expect that this issue to arise more frequently The preliminary data available indicate that the proposed regimen is the safest and most effective to instill donor hematopoiesis after the initial graft has been rejected
We also wish to evaluate the safety and effectiveness of Tacrolimus and MMF as GVHD prophylaxis in patients receiving a second transplant TacMMF is our current GVHD prophylaxis regimen It has proven to be well tolerated and provide good protection against GVHD even in heavily pretreated patients We propose to use this standard first transplant GVHD prophylaxis to prevent GVHD after second transplantation DLI may be given in the presence of disease progression or for mixed chimerism as clinically indicated
We also wish to evaluate the safety and effectiveness of Tacrolimus and MMF as GVHD prophylaxis in patients receiving a second transplant TacMMF is our current GVHD prophylaxis regimen It has proven to be well tolerated and provide good protection against GVHD even in heavily pretreated patients We propose to use this standard first transplant GVHD prophylaxis to prevent GVHD after second transplantation DLI may be given in the presence of disease progression or for mixed chimerism as clinically indicated
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 |
|---|---|---|---|
| CBCI-166 | OTHER | Colorado Blood Cancer Institute | None |