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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: B-cell Non-Hodgkin Lymphoma; Aggressive

Treatments: Other: Peripheral blood tests; Device: PET/CT; Other: collected at pre-treatment tumor biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02633111

15-180

Details and patient eligibility

About

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.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

501 participants in 1 patient group

Patients with aggressive B-cell Non-Hodgkin lymphoma

Description:

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.

Treatment:

Device: PET/CT

Other: collected at pre-treatment tumor biopsy

Other: Peripheral blood tests