Rituximab for Prevention of Chronic GVHD
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|ClinicalTrials.gov Identifier: NCT00379587|
Recruitment Status : Completed
First Posted : September 22, 2006
Results First Posted : March 19, 2014
Last Update Posted : March 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Drug: Rituximab Drug: 375 mg/m2 RRituximab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
- Drug: Rituximab
Rituximab at months 3, 6, 9 and 12 post-transplant
- Drug: 375 mg/m2 RRituximab
Rituximab 375 mg/m2 q3months
- 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 ]
- Incidence of Grade 3 or Higher Infectious Complications [ Time Frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion ]
- Incidence of Relapse or Progression of Disease [ Time Frame: by 4 years after peripheral blood stem cell (PBSC) infusion ]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 ]White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379587
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Corey Cutler||Dana-Farber Cancer Institute|