Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low success rate. These treatments for relapse have significant toxicities and may not be tolerated well by the patients. These patients need an effective means of identifying relapse at an early time point to be treated effectively. Detection of circulating tumor DNA (ctDNA) has been reported to be a sensitive and more specific method to detect relapse at an early stage compared to PET/ CT scans. Purpose of this trial is to monitor patients who have undergone successful chemotherapy for the presence of ctDNA. Patients who test positive for ctDNA would be treated with Nivolumab for a period of 2 years to avoid complete relapse.
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: 1. To evaluate safety of nivolumab as maintenance drug in post-induction, post-salvage and post-autologous transplant setting 2. Relapse free survival (RFS-ctDNA) for nivolumab treated patients 3. Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment 4. To validate NeoLabs assay platform by comparing the results to Clonoseq platform.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients would be given an infusion of 240 mg nivolumab over 30 min
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients
Regular monitoring of ctDNA positive patients on nivolumab until they become ctDNA negative
Time frame: 2 years
Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients
Regular testing of ctDNA in positive patients on nivoluman until clinical relapse
Time frame: 2 years
To evaluate adverse events in patients on nivolumab as maintenance drug in post-induction, post-salvage and post-autologous transplant setting
Safety evaluated by the frequency and grade of adverse events, as defined by NCI CTCAE 4.03 criteria, for patients treated with nivolumab, such as, uveitis, abnormal lab report or intercurrent illness
Time frame: 2 years
Relapse free survival (RFS-ctDNA) for nivolumab treated patients
RFS will be calculated from the day of nivolumab administration until clinical disease
Time frame: 2 years
Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment
Number of patients who are ctDNA positive and treated with nivolumab, turn ctDNA negative
Time frame: 2 years
To compare the ctDNA results of Clonoseq and Neolabs platform
The results obtained from the two platforms will be compared for the feasibility of NeoLabs platform for detecting any change in ctDNA numbers in blood
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.