Status:
UNKNOWN
Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Conditions:
Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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 impair...
Eligibility Criteria
Inclusion
- Age 12-65 years (patient is older than 12.0 and less than 66.0 years old)
- Patients with acute leukemia, myelodysplastic syndrome or lymphoma who scheduled to undergo allogeneic stem-cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors
- Renal function: estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight)
- Hepatic function: Baseline direct bilirubin, alanine aminotransferase (ALT) lower than three times the upper limit of normal
- Pulmonary disease: forced vital capacity (FVC) or forced expiratory volume at one second (FEV1) \> 40% predicted
- Cardiac ejection fraction \> 40%
- Signed informed consent
Exclusion
- Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
- Prior allogeneic transplant
- Karnofsky Performance Score \< 70%
- Patients who are not undergoing standard GVHD prophylaxis with cyclosporine/tacrolimus and methotrexate
- Patients with uncontrolled bacterial, viral or fungal infections
- Patients receiving other investigational drugs for GVHD
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02799888
Start Date
April 1 2014
End Date
April 1 2017
Last Update
June 15 2016
Active Locations (1)
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1
Department of Hematopoietic Stem Cell Transplantation
Beijing, Beijing Municipality, China, 100071