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

Primary Purpose

Graft-versus-host Disease, Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Maraviroc 150 MG
Maraviroc 300 mg
Maraviroc 300 mg Phase II
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft-versus-host Disease focused on measuring Graft-versus-host disease, GVHD, Maraviroc, non-myeloablative allogeneic stem-cell transplantation, Hematopoietic stem cell transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Phase 1: 150mg Maraviroc

    Phase 1: 300mg Maraviroc

    Phase 2: 300mg Maraviroc

    Arm Description

    150mg twice daily

    300mg twice daily

    300mg twice daily

    Outcomes

    Primary Outcome Measures

    Safety of Maraviroc
    number of Adverse Events following exposure to Maraviroc
    Efficacy of Maraviroc
    Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved. If no GVHD was noted following exposure, then efficacy was achieved in that participant

    Secondary Outcome Measures

    Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
    Plasma maraviroc levels were measured in the blood with a target level of 100 ng per milliliter. Blood was drawn on Day 0 and Day 10-12 at pre-dose, 1, 2, 3, 4, 6, and 12 hours post-dose. Data was analyzed looking at the number of patients to achieve the target of 100 ng per milliliter at any time point.
    Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
    count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year
    Rate of Early Mortality After Transplant
    Number of participants who died without relapse within 1 year of SCT
    Number of Participants Who Relapsed During Study Period
    Number of participants who received Maraviroc during SCT who relapsed within 1 year and 11 months. This was based on a diagnosis made by their physician that their primary cancer had returned.

    Full Information

    First Posted
    July 23, 2009
    Last Updated
    April 25, 2022
    Sponsor
    Abramson Cancer Center at Penn Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00948753
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (Actual)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abramson Cancer Center at Penn Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1: 150mg Maraviroc
    Arm Type
    Experimental
    Arm Description
    150mg twice daily
    Arm Title
    Phase 1: 300mg Maraviroc
    Arm Type
    Experimental
    Arm Description
    300mg twice daily
    Arm Title
    Phase 2: 300mg Maraviroc
    Arm Type
    Experimental
    Arm Description
    300mg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Maraviroc 150 MG
    Other Intervention Name(s)
    CCR5 Blockade
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Maraviroc 300 mg
    Other Intervention Name(s)
    CCR5 Blockade
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Maraviroc 300 mg Phase II
    Other Intervention Name(s)
    CCR5 Blockade
    Intervention Description
    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 Measure Information:
    Title
    Safety of Maraviroc
    Description
    number of Adverse Events following exposure to Maraviroc
    Time Frame
    1 year
    Title
    Efficacy of Maraviroc
    Description
    Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved. If no GVHD was noted following exposure, then efficacy was achieved in that participant
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
    Description
    Plasma maraviroc levels were measured in the blood with a target level of 100 ng per milliliter. Blood was drawn on Day 0 and Day 10-12 at pre-dose, 1, 2, 3, 4, 6, and 12 hours post-dose. Data was analyzed looking at the number of patients to achieve the target of 100 ng per milliliter at any time point.
    Time Frame
    pre-dose, 1,2,3,4,6,12 hours post-dose
    Title
    Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
    Description
    count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year
    Time Frame
    1 year
    Title
    Rate of Early Mortality After Transplant
    Description
    Number of participants who died without relapse within 1 year of SCT
    Time Frame
    1 year
    Title
    Number of Participants Who Relapsed During Study Period
    Description
    Number of participants who received Maraviroc during SCT who relapsed within 1 year and 11 months. This was based on a diagnosis made by their physician that their primary cancer had returned.
    Time Frame
    1 year and 11 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Porter, MD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22784116
    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.
    Results Reference
    derived

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

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