Maraviroc as GVHD Prophylaxis in Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02167451|
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diagnoses That Require Stem Cell Transplant Graft Versus Host Disease (GVHD)||Drug: Maraviroc||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).
Other Name: Selzentry
- Feasibility [ Time Frame: Up to day +100 ]The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis.
- GVHD Incidence [ Time Frame: By day +100 ]Clinical data to be collected and reported include the onset of GVHD, grade, organ involved, and treatments used.
- Area Under The Concentration-Time Curve (AUC) of Maraviroc [ Time Frame: Day 0 and day +10 ]pK target >100ng/ml
- Overall survival [ Time Frame: By day +100 ]
- Graft Failure [ Time Frame: By day +100 ]Failure to engraft and loss of graft.
- Primary Disease Relapse [ Time Frame: By day +100 ]
- Toxicities [ Time Frame: Up to day +100 ]Incidence of toxicities either due to drug or transplant.
- Infectious Complications [ Time Frame: Up to day +100 ]Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures.
- Time to Neutrophil and Platelet Engraftment [ Time Frame: Up to day +100 ]Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days.
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): NCT02167451
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Pooja Khandelwal, MD||Children's Hospital Medical Center, Cincinnati|