An observational study in Peripheral T Cell Lymphoma, sponsored by Washington University School of Medicine. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Washington University School of Medicine · Observational
As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be performed in peripheral blood, the investigators wish to evaluate the ability of this assay to predict which patients are at higher risk of relapse after initial therapy for peripheral T-cell lymphomas which is being given for curative intent. Additionally, as more is known about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to predict relapse, the investigators wish to explore the use of this technology in T-cell lymphomas.
Participants with peripheral T cell lymphoma who are seen in clinics associated with the participating locations
Availability of pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype, or willingness to undergo biopsy if sufficient tissue is not available at time of enrollment (e.g. 15 slides from fixed formalin-fixed paraffin embedded tumor tissue
*Patients who have less than 15 slides of fixed formalin-fixed paraffin embedded tumor tissue may be considered for enrollment after discussion with the study principal investigator
Exclusion Criteria:
-Patients will be treated with frontline chemotherapy per the treating physician's discretion. Collection of the pre-treatment tumor biopsy to identify the tumor-specific clonotype and peripheral blood samples at various time points for assessment of minimal residual disease using the LymphoTrack MRD assay. The results of these studies will be performed in batches and therefore will not be available to patients and clinicians to make clinical decisions.
Procedure: Tumor biopsy · Procedure: Peripheral blood draw · Procedure: Lymphotrack TCR clonality assay
Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load
-Baseline, C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, end of treatment, 3 month follow-up (optional), 6 month follow-up, 9 month follow-up (optional), 12 month follow-up, 15 month follow-up (optional), 18 month follow-up, 21 month follow-up (optional), 24 month follow-up, and at relapse
-Assay with high sensitivity that can be performed with peripheral blood
Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
Time frame: 2 years
Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by the ability of Lymphotrack to detect minimal residual disease in at least 60% of baseline samples
Time frame: Baseline
Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse
Time frame: Through 2 years
Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen
Time frame: Baseline
Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment
Time frame: Through 2 years
Rate of decline of the tumor specific sequence or sequences predict duration of response
Time frame: Through 2 years
Characterize the lead time from MRD positivity to subsequent clinical relapse
Time frame: Through 2 years
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine