Clinical trial · Interventional
Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation
Safety and Efficacy of Maraviroc-Based Graft-Versus-Host-Disease Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Donor Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor) hematopoietic stem cell transplantation (HSCT) is associated with increased graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5) antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this study is to evaluate the safety and efficacy of maraviroc combined with standard graft-versus-host-disease prophylaxis in patients with hematologic malignancies after allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors. Based on the results of our previously small sample study with maraviroc combined with cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to perform the clinical trail.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-versus-host Disease | — | UNRESOLVED | — |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclosporine (in HLA-Unrelated Donor Transplantation) | Drug | — | UNRESOLVED |
| Maraviroc | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tacrolimus (in HLA-Mismatched Related Donor Transplantation) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maraviroc + standard GVHD prophylaxis
- description
- Maraviroc administration (in addition to the standard prophylaxis therapy of cyclosporine/tacrolimus and methotrexate) will start on day -2 and will end on day +30 after stem cell transplant, making the total number of days of drug administration 33 days. Maraviroc will be administered 300mg twice daily orally.
- interventionNames
- Drug: Maraviroc
- Drug: Cyclosporine (in HLA-Unrelated Donor Transplantation)
- Drug: Tacrolimus (in HLA-Mismatched Related Donor Transplantation)
- Drug: Methotrexate
Primary outcomes (1)
- measure
- Incidence of Acute GVHD Grades II-IV
- timeFrame
- 1 Year
Secondary outcomes (8)
- measure
- Incidence of Acute GVHD Grades III-IV
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 12-65 years (patient is older than 12.0 and less than 66.0 years old) 2. Patients with acute leukemia, myelodysplastic syndrome or lymphoma who scheduled to undergo allogeneic stem-cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors 3. Renal function: estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight) 4. Hepatic function: Baseline direct bilirubin, alanine aminotransferase (ALT) lower than three times the upper limit of normal 5. Pulmonary disease: forced vital capacity (FVC) or forced expiratory volume at one second (FEV1) \> 40% predicted 6. Cardiac ejection fraction \> 40% 7. Signed informed consent Exclusion Criteria: 1. Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant 2. Prior allogeneic transplant 3. Karnofsky Performance Score \< 70% 4. Patients who are not undergoing standard GVHD prophylaxis with cyclosporine/tacrolimus and methotrexate 5. Patients with uncontrolled bacterial, viral or fungal infections 6. Patients receiving other investigational drugs for GVHD
References
Publications (0)
Data not yet available