Clinical trial NCT00948753: Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
Official title: Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Keywords: Graft-versus-host disease
GVHD
Maraviroc
non-myeloablative allogeneic stem-cell transplantation
Hematopoietic stem cell transplantation
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Safety of Maraviroc
timeFrame: 1 year
measure: Efficacy of Maraviroc
timeFrame: 8 weeks
Secondary outcomes:
measure: Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
timeFrame: pre-dose, 1,2,3,4,6,12 hours post-dose
measure: Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
timeFrame: 1 year
measure: Rate of Early Mortality After Transplant
timeFrame: 1 year
measure: Number of Participants Who Relapsed During Study Period
timeFrame: 1 year and 11 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: David Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reshef R, Luger SM, Hexner EO, Loren AW, Frey NV, Nasta SD, Goldstein SC, Stadtmauer EA, Smith J, Bailey S, Mick R, Heitjan DF, Emerson SG, Hoxie JA, Vonderheide RH, Porter DL. Blockade of lymphocyte chemotaxis in visceral graft-versus-host disease. N Engl J Med. 2012 Jul 12;367(2):135-45. doi: 10.1056/NEJMoa1201248.