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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02633111
Other study ID # 15-180
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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