Phase 2
Completed N=13
Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
graft-versus-host disease · Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov NCT00948753 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Safety of Maraviroc — 8; 6; 18 Number of AEs
Summary
This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Maraviroc |
8; 6; 18 | — |
| PRIMARY Efficacy of Maraviroc |
0; 0; 0 | — |
| SECONDARY Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT |
4; 6; 0 | — |
| SECONDARY Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD |
1; 3; 2 | — |
| SECONDARY Rate of Early Mortality After Transplant |
2; 0; 4 | — |
| SECONDARY Number of Participants Who Relapsed During Study Period |
2; 2; 15 | — |
Eligibility Criteria
Inclusion Criteria
- patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
- meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
- Renal function: Serum creatinine 40 mL/min/1.72m2;
- Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
- Pulmonary disease: FVC or FEV1 > 40% predicted; Cardiac ejection fraction > 40%.
Exclusion Criteria
- Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
- Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
- Patients with uncontrolled bacterial, viral or fungal infections
- Patients who take strong inducers or inhibitors of the CYP450A4
- Patients receiving other investigational drugs for GVHD
- Women who are pregnant, plan to become pregnant or are breastfeeding
Data sourced from ClinicalTrials.gov (NCT00948753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.