Maraviroc as GVHD Prophylaxis in Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02167451|
Recruitment Status : Terminated (slow recruitment and no further drug supply)
First Posted : June 19, 2014
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
|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 of Maraviroc [ 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 ]Incidence of GVHD by day+100
- Area Under The Concentration-Time Curve (AUC) of Maraviroc [ Time Frame: Day 0 ]pK target >100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
- Incidence of Visceral GVHD [ Time Frame: day+100 ]determine the number of patients who develop visceral GVHD by day+100
- Area Under The Concentration-Time Curve (AUC) of Maraviroc [ Time Frame: Day 10 ]pK target >100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
- Overall Survival [ Time Frame: By day +100 ]Overall survival for patients who were enrolled and received maraviroc
- 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 due to drug
- 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 [ 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.
- Time to Platelet Engraftment [ Time Frame: days ]Time to achieve platelets count of 20,000 without transfusions
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|