Maraviroc as GVHD Prophylaxis in Transplant Recipients
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02167451|
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : May 7, 2018
|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|
|Estimated Enrollment :||65 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|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
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
|Contact: Melanie Jordan||513-636-4379||Melanie.Jordan@cchmc.org|
|Contact: Stephanie Edwards, BSN, RN||513-636-9292||StephanieL.Edwards@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Sharon Mitchell 513-636-4174 Sharon.Mitchell@cchmc.org|
|Principal Investigator:||Pooja Khandelwal, MD||Children's Hospital Medical Center, Cincinnati|