Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Diffuse Large B Cell Lymphoma
- HIV
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
The study is a single-center, non-randomized phase II clinical trial of R-CHOP for CD20-positive DLBCL, using the Indian generic biosimilar for rituximab, Reditux™. The investigators will enroll 40 adult patients age 18-60 years (20 HIV-infected with CD4 count ? 100 cells/µL, 20 HIV-uninfected) who ...
The study is a single-center, non-randomized phase II clinical trial of R-CHOP for CD20-positive DLBCL, using the Indian generic biosimilar for rituximab, Reditux™. The investigators will enroll 40 adult patients age 18-60 years (20 HIV-infected with CD4 count ? 100 cells/µL, 20 HIV-uninfected) who will receive a maximum of 6-8 cycles of R-CHOP over 18-24 weeks. The primary goal of this study is to establish the safety of R-CHOP in the Malawi population. Secondary objectives of the study include estimates of complete response (CR) rates, progression-free survival (PFS), and overall survival (OS). In addition, quality of life, costs of care, study patient characteristics, clinical outcomes and other published data from the region will be collected and used to evaluate the cost-effectiveness of R-CHOP. If the investigators' study supports incorporating rituximab into treatment regimens in sub-Saharan Africa, this strategy can be examined in larger trials, and provide momentum to increase access to modern cancer medicines globally.
Tracking Information
- NCT #
- NCT02660710
- Collaborators
- Fogarty International Center of the National Institute of Health
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Matthew Painschab, MD University of North Carolina