NCT03297697|CompletedDMC
Minimal Residual Disease in Peripheral T-cell Lymphoma
A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma
Loading search results
A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma
Sponsor study identifier
Secondary identifiers
observational
44
1 country
3
Study Start
July 31, 2017
Actual (reported)Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 31, 2017
Actual (reported)September 26, 2017
Actual (reported)September 29, 2017
Actual (reported)November 30, 2023
Actual (reported)November 30, 2023
Actual (reported)Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
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
Baseline
Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse
Through 2 years
Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen
Baseline
Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment
Through 2 years
Rate of decline of the tumor specific sequence or sequences predict duration of response
Through 2 years
-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.
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
Participants with peripheral T cell lymphoma who are seen in clinics associated with the participating locations
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Blood, bone marrow, and tissue
Neha Mehta-Shah, M.D.
Washington University School of Medicine
44 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2017
First Posted
September 29, 2017
Study Start
July 31, 2017
Actual (reported)-Assay with high sensitivity that can be performed with peripheral blood
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Last Updated
May 16, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: