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Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00948753
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Graft-versus-host Disease Hematopoietic Stem Cell Transplantation Drug: Maraviroc 150 MG Drug: Maraviroc 300 mg Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

Arm Intervention/treatment
Experimental: Phase 1: 150mg Maraviroc
150mg twice daily
Drug: Maraviroc 150 MG
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Experimental: Phase 1: 300mg Maraviroc
300mg twice daily
Drug: Maraviroc 300 mg
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Experimental: Phase 2: 300mg Maraviroc
300mg twice daily
Drug: Maraviroc 300 mg
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.




Primary Outcome Measures :
  1. Efficacy and safety of Maraviroc in prevention of acute GVHD in patients undergoing non-myeloablative allogeneic SCT. [ Time Frame: Final analysis ]

Secondary Outcome Measures :
  1. Explore pharmacokinetic profile of Maraviroc in patients undergoing nonmyeloablative allogeneic SCT [ Time Frame: Final analysis ]
  2. Assess early mortality after transplant, rate of complications, chronic GVHD and relapse rate in patients treated with Maraviroc during SCT [ Time Frame: Final analysis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948753


Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: David Porter, MD University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948753    
Other Study ID Numbers: UPCC 04708
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Graft-versus-host disease
GVHD
Maraviroc
non-myeloablative allogeneic stem-cell transplantation
Hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists