Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02178683|
Recruitment Status : Unknown
Verified June 2014 by Peter McSweeney, M.D., Colorado Blood Cancer Institute.
Recruitment status was: Recruiting
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: Tacrolimus and MMF.||Phase 3|
Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from an HLA-Identical or non-identical family donor or unrelated donors, with fludarabine and low-dose TBI, with immunosuppression utilizing tacrolimus and MMF.
B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
C. To evaluate the engraftment when donors who are not HLA-identical family members are utilized for allogeneic stem cell transplantation.
D. To evaluate the incidence of GVHD using three times per day MMF after unrelated donor stem cell transplants or two times per day MMF after family donor stem cell transplant.
Minor Objectives A. To evaluate the incidence of chronic GVHD utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched allogeneic donors.
B. To evaluate disease responses and survival after Flu/TBI allogeneic SCT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor HCT|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
No Intervention: Tacrolimus and Mycophenolate Mofetil
Non-myeloablative allogeneic SCT from an HLA-Identical or non-identical family onor or unrelated donors, with fludarabine and low-dose TBI, with immunosuppression utilizing tacrolimus and MMF.
Drug: Tacrolimus and MMF.
First dose of Tacrolimus is given day -4, this continues through day +365. First dose of MMF is given within 4 hours of stem cell infusion, this continues through day +365.
- Engraftment [ Time Frame: Post 100 days ]To measure safe, stable engraftment using Tacrolimus and Mycophenolate Mofetil as post-grafting immunosuppression in patients following conditioning with fludarabine and total-body irradiation for allogeneic stem cell transplant.
- Graft Versus Host Disease [ Time Frame: Post 100 days ]To measure the incidence of grade II-IV GVHD associated with Tacrolimus and Mycophenolate Mofetil as post-grafting immunosuppression.
- Survival [ Time Frame: Post 100 days ]Overall survival will be followed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178683
|Contact: Juli Murphy||720-754-4890||Juli.Murphy@healthonecares.com|
|Contact: Nicole Stephens, RN||720-754-4891||Nicole.Stephens@healthonecares.com|
|United States, Colorado|
|Colorado Blood Cancer Institute||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Juli B Murphy 720-754-4890 Juli.Murphy@healthonecares.com|
|Contact: Mark Brunvand, MD 720-754-4800 Mark.Brunvand@healthonecares.com|
|Principal Investigator: Mark Brunvand, MD|
|Sub-Investigator: Peter McSweeney, MD|
|Sub-Investigator: Michael Maris, MD|
|Sub-Investigator: Jeff Matous, MD|
|Sub-Investigator: Scott Bearman, MD|
|Sub-Investigator: Tara Gregory, MD|
|Sub-Investigator: Richard Nash, MD|
|Principal Investigator:||Mark W Brunvand, MD||Colorado Blood Cancer Institute|