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Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Graft-versus-host Disease, Hematopoietic Stem Cell Transplantation

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Trial Information

Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation


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 aren ot 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy and safety of Maraviroc in prevention of acute GVHD in patients undergoing non-myeloablative allogeneic SCT.

Outcome Time Frame:

Final analysis

Safety Issue:

Yes

Principal Investigator

David Porter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 04708

NCT ID:

NCT00948753

Start Date:

June 2009

Completion Date:

April 2012

Related Keywords:

  • Graft-Versus-Host Disease
  • Hematopoietic Stem Cell Transplantation
  • Graft-versus-host disease
  • GVHD
  • Maraviroc
  • non-myeloablative allogeneic stem-cell transplantation
  • Hematopoietic stem cell transplantation
  • Graft vs Host Disease

Name

Location

University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104