Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379587
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2006-09-21
Brief Title:
Rituximab for Prevention of Chronic GVHD
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs-Host Disease After Allogeneic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2014-02
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:
The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another After the transplant the donor immune system may recognize the recipient body as foreign and may attempt to reject the body Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them
Detailed Description:
Study Design The study is designed as a Phase II open label trial of Rituximab as chronic GVHD prophylaxis after HLA-matched related or unrelated peripheral blood stem cell transplantation after ablative or non-ablative conditioning
Primary Objective To determine the incidence of clinically extensive chronic GVHD at one and two years after allogeneic stem cell transplantation after a single dose of Rituximab administered at 100 days 6 months 9 months and 1 year from transplantation as chronic GVHD prophylaxis
Secondary Objectives To determine the incidence of adverse hematological events the incidence of infectious complications the rate of malignant relapse and the effects on donor hematopoietic chimerism after Rituximab administration
Eligibility Criteria Eligible patients will be 18 years of age or greater and will have undergone a non-myeloablative or fully ablative transplantation from an HLA-matched 66 loci or single antigenallele mismatched 56 donor approximately 100 days ago Adequate performance status and organ function will be confirmed prior to enrollment No ongoing infection or acute GVHD will be present at the time of enrollment Evidence of sustained donor chimerism will be confirmed prior to study entry
Treatment Description Chronic GVHD prophylaxis will consist of Rituximab 375 mgm2 administered 100 days 6 9 and 12 months after transplantation
Accrual Objective 68 patients will be accrued over 12 months
Study Duration Patients will be evaluated for two years after the time of transplantation for evaluation of the primary and secondary endpoints Subjects will be followed longitudinally after completion of the study period for determination of clinical status
Primary Objective To determine the incidence of clinically extensive chronic GVHD at one and two years after allogeneic stem cell transplantation after a single dose of Rituximab administered at 100 days 6 months 9 months and 1 year from transplantation as chronic GVHD prophylaxis
Secondary Objectives To determine the incidence of adverse hematological events the incidence of infectious complications the rate of malignant relapse and the effects on donor hematopoietic chimerism after Rituximab administration
Eligibility Criteria Eligible patients will be 18 years of age or greater and will have undergone a non-myeloablative or fully ablative transplantation from an HLA-matched 66 loci or single antigenallele mismatched 56 donor approximately 100 days ago Adequate performance status and organ function will be confirmed prior to enrollment No ongoing infection or acute GVHD will be present at the time of enrollment Evidence of sustained donor chimerism will be confirmed prior to study entry
Treatment Description Chronic GVHD prophylaxis will consist of Rituximab 375 mgm2 administered 100 days 6 9 and 12 months after transplantation
Accrual Objective 68 patients will be accrued over 12 months
Study Duration Patients will be evaluated for two years after the time of transplantation for evaluation of the primary and secondary endpoints Subjects will be followed longitudinally after completion of the study period for determination of clinical status
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