Clinical trial NCT02799888: Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation
Official title: Safety and Efficacy of Maraviroc-Based Graft-Versus-Host-Disease Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Donor Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Keywords: Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Acute Leukemia
Myelodysplastic syndrome
Lymphoma
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.


Eligibility 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

Primary outcomes:
measure: Incidence of Acute GVHD Grades II-IV
timeFrame: 1 Year
Secondary outcomes:
measure: Incidence of Acute GVHD Grades III-IV
timeFrame: By day +100 post-HSCT
measure: Incidence of Chronic GVHD
timeFrame: 1 Year
measure: Hematologic Recovery (Neutrophils and Platelets)
timeFrame: Up to day +100 post-HSCT
measure: Disease Relapse or Progression
timeFrame: 1 Year
measure: Incidence of Transplant-Related Mortality
timeFrame: By day +100 post-HSCT
measure: Frequency of Grade 3 or Greater Toxicities
timeFrame: Up to day +100 post-HSCT
measure: Incidence of Grade 2 and 3 Infections
timeFrame: 1 Year
measure: Overall Survival
timeFrame: 1 Year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematopoietic Stem Cell Transplantation
state: Beijing
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Hu Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: