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Sponsored by: |
Rocky Mountain Blood and Marrow Transplant Program |
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Information provided by: | Rocky Mountain Blood and Marrow Transplant Program |
ClinicalTrials.gov Identifier: | NCT00472329 |
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 | Intervention | 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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any patient who has rejected a previous allogeneic transplant (related or unrelated) rejection based on chimerism data from peripheral blood specimens showing loss of donor T Cells.
Exclusion Criteria:
Organ dysfunction felt to be due to the conditioning for the first transplant including the following:
Patients with these end-organ toxicities may be presented to the RMBMTP Patient Care Conference. If the majority opinion is that this treatment is the safest option for a patient who has rejected their first transplant, they will be allowed to undergo the treatment, after informed consent has been signed.
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 | Rocky Mountain Blood and Marrow Transplant Program |
Study ID Numbers: | RMBMT-166-A |
Study First Received: | May 10, 2007 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00472329 |
Health Authority: | United States: Institutional Review Board |
Fludarabine Fludarabine monophosphate |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |