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Completed

NCT Number: NCT00948753

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

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Hematopoietic Stem Cell Transplantation Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maraviroc 150 MG

Drug

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.

Other names: CCR5 Blockade

Maraviroc 300 mg

Drug

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.

Other names: CCR5 Blockade

Maraviroc 300 mg Phase II

Drug

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.

Other names: CCR5 Blockade

Primary outcomes

  1. Safety of Maraviroc

    Time frame: 1 year

    number of Adverse Events following exposure to Maraviroc

  2. Efficacy of Maraviroc

    Time frame: 8 weeks

    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 outcomes

  1. Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT

    Time frame: pre-dose, 1,2,3,4,6,12 hours post-dose

    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.

  2. Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD

    Time frame: 1 year

    count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year

  3. Rate of Early Mortality After Transplant

    Time frame: 1 year

    Number of participants who died without relapse within 1 year of SCT

  4. Number of Participants Who Relapsed During Study Period

    Time frame: 1 year and 11 months

    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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2009
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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