Rituximab for Prevention of Chronic GVHD
Drug: 375 mg/m2 RRituximab
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation|
- Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years [ Time Frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion ] [ Designated as safety issue: Yes ]
- Incidence of Grade 3 or Higher Infectious Complications [ Time Frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion ] [ Designated as safety issue: Yes ]
- Incidence of Relapse or Progression of Disease [ Time Frame: by 4 years after peripheral blood stem cell (PBSC) infusion ] [ Designated as safety issue: Yes ]Percentage of participants with relapsed disease by year 4 post transplant.
- Incidence of Adverse Hematological Events [ Time Frame: by 18 months after peripheral blood stem (PBSC) infusion ] [ Designated as safety issue: Yes ]White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.
|Study Start Date:||September 2006|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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 (6/6 loci) or single antigen/allele mismatched (5/6) 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 mg/m2 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379587
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Corey Cutler||Dana-Farber Cancer Institute|