Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor
|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: NCT00304720|
Recruitment Status : Unknown
Verified March 2004 by Colorado Blood Cancer Institute.
Recruitment status was: Recruiting
First Posted : March 20, 2006
Last Update Posted : February 8, 2008
A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF.
B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Lymphoma Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome||Drug: Tacrolimus and MMF||Phase 2|
- Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
- Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration.
Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 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 Family Donor Hematopoietic Cell Transplants|
|Study Start Date :||March 2004|
- The main endpoints are day 100 mortality and acute GVHD.
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): NCT00304720
|United States, Colorado|
|Rocky Mountain Blood and Marrow Transplant Program||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Peter A McSweeney, MD 303-336-2184 Peter.McSweeney@usoncology.com|
|Contact: Juli B Murphy 303-285-5087 Juli.Murphy@usoncology.com|
|Sub-Investigator: Robert M Rifkin, MD|
|Principal Investigator: Peter A McSweeney, MD|
|Sub-Investigator: Jeffrey V Matous, MD|
|Sub-Investigator: Scott I Bearman, MD|
|Sub-Investigator: Mark W Brunvand, MD|
|Sub-Investigator: Michael B Maris, MD|
|Principal Investigator:||Peter A McSweeney, MD||Colorado Blood Cancer Institute|