Maraviroc as GVHD Prophylaxis in Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 5 - 40 |
| Updated: | 3/23/2019 |
| Start Date: | July 2014 |
| End Date: | September 2018 |
Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients
The purpose is to determine if the addition of Maraviroc to a standard transplant regimen
will reduce the incidence of graft versus host disease in children and young adults after a
stem cell transplant.
will reduce the incidence of graft versus host disease in children and young adults after a
stem cell transplant.
In the first stage, drug levels will be obtained to establish appropriate dosing. In the
second stage of the study the investigators will study the effects of using Maraviroc in
these patients.
second stage of the study the investigators will study the effects of using Maraviroc in
these patients.
Inclusion Criteria:
- Ages 5 years and
- All diagnoses
- Peripheral blood stem cells, marrow or cord blood
- All conditioning regimens
- Patient must be planned to receive a calcineurin inhibitor (cyclosporine or
tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD
prophylaxis.
Exclusion Criteria:
- Documented anaphylaxis to Maraviroc
- Ex vivo T-cell (type of white blood cell) depleted grafts
- Abnormal Alanine Aminotransferase (ALT) (>/=10X ULN) on day -3. (Assessed at study
enrollment and confirmed again prior to the first dose of maraviroc.)
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-636-4174
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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