Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01785810
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2013-02-05
Brief Title:
Phase II Maraviroc for GVHD Prevention
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Phase II Study to Assess the Efficacy of Maraviroc in Prophylaxis of GVHD in Patients With Hematologic Malignancies Undergoing Reduced-Intensity Allogeneic SCT From Unrelated Donors
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Successful allogeneic stem-cell transplantation is often limited by graft-versus-host disease GVHD Migration of donor cells into tissues plays a major role in GVHD Drugs that block chemokine receptors such as CCR5 can potentially decrease the migration of donor cells into tissues Blocking CCR5 after allogeneic stem-cell transplantation may therefore reduce the rates of GVHD
PURPOSE This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced intensity conditioning
PURPOSE This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced intensity conditioning
Detailed Description:
Detailed Description
PRIMARY OBJECTIVES
To estimate the cumulative incidence of grade 2-4 acute GVHD by day 180 with the addition of maraviroc to a standard prophylaxis regimen in patients with hematologic malignancies undergoing reduced intensity allogeneic stem-cell transplantation RIC SCT from unrelated donors
SECONDARY OBJECTIVES
1 To assess the toxicity of a prolonged administration of maraviroc in patients undergoing RIC SCT
2 To estimate the rates of severe grade 3-4 acute GVHD by day 100 and 180 grade 2-4 acute GVHD by day 100 organ-specific acute GVHD chronic GVHD relapse infections non-relapse mortality use of immunosuppressive therapies and 1-year survival in patients treated with maraviroc after RIC SCT
3 To assess the effect of treatment with maraviroc on immune recovery engraftment and donor T-cell chimerism in peripheral blood and in target organs
4 To assess the effect of donor and recipient CCR5 genotype on the incidence of acute GVHD in patients receiving maraviroc as part of a GVHD prophylaxis regimen
OUTLINE Patients receive a standard conditioning regimen with fludarabine and busulfan followed by a peripheral blood stem cell infusion from an unrelated donor standard GVHD prophylaxis and standard antiviral and antifungal prophylaxis In addition all patients receive maraviroc from day -3 to d 90
Patients are followed for 1 year after the stem-cell infusion
PRIMARY OBJECTIVES
To estimate the cumulative incidence of grade 2-4 acute GVHD by day 180 with the addition of maraviroc to a standard prophylaxis regimen in patients with hematologic malignancies undergoing reduced intensity allogeneic stem-cell transplantation RIC SCT from unrelated donors
SECONDARY OBJECTIVES
1 To assess the toxicity of a prolonged administration of maraviroc in patients undergoing RIC SCT
2 To estimate the rates of severe grade 3-4 acute GVHD by day 100 and 180 grade 2-4 acute GVHD by day 100 organ-specific acute GVHD chronic GVHD relapse infections non-relapse mortality use of immunosuppressive therapies and 1-year survival in patients treated with maraviroc after RIC SCT
3 To assess the effect of treatment with maraviroc on immune recovery engraftment and donor T-cell chimerism in peripheral blood and in target organs
4 To assess the effect of donor and recipient CCR5 genotype on the incidence of acute GVHD in patients receiving maraviroc as part of a GVHD prophylaxis regimen
OUTLINE Patients receive a standard conditioning regimen with fludarabine and busulfan followed by a peripheral blood stem cell infusion from an unrelated donor standard GVHD prophylaxis and standard antiviral and antifungal prophylaxis In addition all patients receive maraviroc from day -3 to d 90
Patients are followed for 1 year after the stem-cell infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None