Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diffuse Large B Cell Lymphoma
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Regular testing of DLBCL patients who have successfully undergone chemotherapy and are negative for ctDNA. Treatment of patients who become positive for ctDNA with NivolumabMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: To determine if nivolumab administration, as a maintenance strategy in DLBCL patients with high risk of relapse, can convert positive ctDNA to negative ctDNA and/or result in relapse free survival (RFS-ctDNA) of 9 months or longer after positive ctDNA was documented. Secondary Obj...
Primary Objective: To determine if nivolumab administration, as a maintenance strategy in DLBCL patients with high risk of relapse, can convert positive ctDNA to negative ctDNA and/or result in relapse free survival (RFS-ctDNA) of 9 months or longer after positive ctDNA was documented. Secondary Objectives: To evaluate safety of nivolumab as maintenance drug in post-induction, post-salvage and post-autologous transplant setting Relapse free survival (RFS-ctDNA) for nivolumab treated patients Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment To validate NeoLabs assay platform by comparing the results to Clonoseq platform.
Tracking Information
- NCT #
- NCT03311958
- Collaborators
- Not Provided
- Investigators
- Not Provided
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