Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Diffuse Large B Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: Establishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2) Secondary Objectives: Determine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL. Determine the proportion of patients who proceed to aut...
Primary Objective: Establishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2) Secondary Objectives: Determine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL. Determine the proportion of patients who proceed to autologous stem cell transplantation after V+RICE relative to historical controls. Describe the progression-free survival (PFS) and overall survival (OS) for patients treated with V + RICE who do and do not proceed to auto-Stem Cell Transplant, relative to historical controls. Measure total number of peripheral blood stem cells collected in patients treated with V + RICE who proceed to stem cell mobilization/harvesting, compared to historical controls.
Tracking Information
- NCT #
- NCT03064867
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paolo Caimi, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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