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

B-cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02633111
• Other study ID #: 15-180
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 501
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Aggressive
• B-cell Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Neoplasm, Residual

Intervention

Other:
• collected at pre-treatment tumor biopsy
to identify the tumor-specific clonotype
• 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)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	Harrison	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Md Anderson Cancer Center	Houston	Texas
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	M.D. Anderson Cancer Center, Mayo Clinic, University of Miami, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRD assay to predict clinical relapse	using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center