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

Hematopoietic Stem Cell Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948753
• Other study ID #: UPCC 04708
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host Disease
• Hematopoietic Stem Cell Transplantation

Intervention

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.
• 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.
• Maraviroc 300 mg Phase II
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Maraviroc	number of Adverse Events following exposure to Maraviroc	1 year
Primary	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	8 weeks
Secondary	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.	pre-dose, 1,2,3,4,6,12 hours post-dose
Secondary	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	1 year
Secondary	Rate of Early Mortality After Transplant	Number of participants who died without relapse within 1 year of SCT	1 year
Secondary	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.	1 year and 11 months