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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00472329|
Recruitment Status : Recruiting
First Posted : May 11, 2007
Last Update Posted : June 30, 2014
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 (150mg/m2) 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 Tac/MMF 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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Failure||Procedure: Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors Drug: fludarabine Procedure: TBI||Phase 2|
This protocol will evaluate the use of Fludarabine (150mg/m2) 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 Flu/TBI 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. Tac/MMF 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|No Intervention: Fludarabine and 400cGY TBI||Procedure: Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors Drug: fludarabine Procedure: TBI|
- Stable allogeneic hematopoietic engraftment with fludarabine (150mg/m2) and TBI (400cGy), with post-transplantation immunosuppression utilizing tacrolimus and MMF. [ Time Frame: Overall disease free survival ]
- Incidence of acute and chronic GVHD after second allogeneic HCT utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched allogeneic donors, disease responses and survival after second allogeneic SCT. [ Time Frame: Overall management of acute and chronic GVHD ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472329
|Contact: Juli Murphy||303-285-5087||Juli.Murphy@usoncology.com|
|Contact: Nicole Stephens||303-336-2183||Nicole.Stephens@usoncology.com|
|United States, Colorado|
|Rocky Mountain Blood and Marrow Transplant Program||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Juli Murphy 303-285-5087 Juli.Murphy@usoncology.com|
|Contact: Nicole Stephens 303-336-2183 Nicole.Stephens@usoncology.com|
|Principal Investigator: Mark W Brunvand, MD|
|Sub-Investigator: Robert M Rifkin, MD|
|Sub-Investigator: Jeffrey V Matous, MD|
|Sub-Investigator: Peter A McSweeney, MD|
|Sub-Investigator: Scott I Bearman, MD|
|Sub-Investigator: Michael B Maris, MD|
|Principal Investigator:||Mark W Brunvand, MD||Colorado Blood Cancer Institute|