Overview

Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation

Status:
Unknown status

Trial end date:
2017-04-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Affiliated Hospital to Academy of Military Medical Sciences

Treatments:

Cyclosporine
Cyclosporins
Maraviroc
Methotrexate
Tacrolimus

Criteria

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