Status:
COMPLETED
Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 (GVH...
Eligibility Criteria
Inclusion
- patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
- meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
- Renal function: Serum creatinine \<2; or calculated creatinine clearance \> 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00948753
Start Date
June 1 2009
End Date
April 1 2011
Last Update
May 17 2022
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