DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02633111

Collaborator

Mayo Clinic (Other), M.D. Anderson Cancer Center (Other), University of Pennsylvania (Other), University of Miami (Other)

501

Enrollment

Locations

Anticipated Duration (Months)

41.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.

Condition or Disease	Intervention/Treatment	Phase
B-cell Non-Hodgkin Lymphoma Aggressive	Other: collected at pre-treatment tumor biopsy Other: Peripheral blood tests Device: PET/CT

Study Design

Study Type:

Observational

Actual Enrollment :

501 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with aggressive B-cell Non-Hodgkin lymphoma This is a non-therapeutic protocol aimed to assess the ability of Adaptive clonoSEQ® MRD assay to detect clinical relapse in DLBCLwhen compared to conventional approaches for detecting relapse such as patient-reported symptoms, clinical exams, and CT scans.	Other: collected at pre-treatment tumor biopsy to identify the tumor-specific clonotype Other: Peripheral blood tests for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month). Device: PET/CT at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)

Arm

Intervention/Treatment

Patients with aggressive B-cell Non-Hodgkin lymphoma

This is a non-therapeutic protocol aimed to assess the ability of Adaptive clonoSEQ® MRD assay to detect clinical relapse in DLBCLwhen compared to conventional approaches for detecting relapse such as patient-reported symptoms, clinical exams, and CT scans.

Other: collected at pre-treatment tumor biopsy

to identify the tumor-specific clonotype

Other: Peripheral blood tests

for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).

Device: PET/CT

at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)

Outcome Measures

Primary Outcome Measures

MRD assay to predict clinical relapse [2 years]
using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age at time of signing informed consent
Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma
De novo diffuse large B-cell lymphoma (including all subtypes such as primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma). According to the 2008 WHO Classification of Hematopoietic and Lymphoid Tumors. These would include double or triple-hit diffuse large B-cell lymphomas with MYC/BCL2 and/or BCL6 gene rearrangements. These cases may be classified as high grade B-cell lymphomas according to the 2017 revision of the WHO Classification of Hematopoietic and Lymphoid Tumors.
Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.

Exclusion Criteria:

Patients receiving 2nd or greater line of therapy.
Stage I or II disease.
Primary mediastinal B-cell lymphoma.
Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States
2	Mayo Clinic	Rochester	Minnesota	United States	55902
3	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
4	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
5	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
6	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
7	Memorial Sloan Kettering Cancer Center	Harrison	New York	United States	10604
8	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
9	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
10	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553
11	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
12	Md Anderson Cancer Center	Houston	Texas	United States	77030