Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation|
- Incidence of Acute GVHD [ Time Frame: Assessed first 6 months post transplant ]Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
- Safety Defined by Serious Adverse Events [ Time Frame: Assessed first 6 months post transplant ]Counted the number of participants that experienced any type of grade 3 or higher toxicity.
- Severity of Acute GVHD [ Time Frame: Assessed first 6 months post transplant ]Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
- Determine Incidence of Opportunistic Infections [ Time Frame: Followed for up to two years post transplant ]
- Estimate Incidence of Chronic GVHD at Two Years [ Time Frame: Followed for up to two years post transplant ]Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks
- Overall Survival at Two Year, [ Time Frame: Followed for up to two years post transplant ]
- Determine Time to Engraftment [ Time Frame: Followed for up to two years post transplant ]Time to engraftment ("G500")
- Determine Time to Engraftment [ Time Frame: Followed for up to two years post transplant ]Time to engraftment ("PLT20")
|Study Start Date:||November 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Tacrolimus and Thymoglobulin
Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Drug: Tacrolimus and Thymoglobulin
Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
Other Name: PROGRAF®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246206
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Zaid Al-Kadhimi, M.D.||Barbara Ann Karmanos Cancer Institute|