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Minimal Residual Disease in Peripheral T-cell Lymphoma

NCT03297697 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2024-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral T Cell Lymphoma

Interventions

PROCEDURE

Tumor biopsy

Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load

PROCEDURE

Peripheral blood draw

-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

PROCEDURE

Lymphotrack TCR clonality assay

-Assay with high sensitivity that can be performed with peripheral blood

Sponsors & Collaborators

  • Invivoscribe, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • T-Cell Leukemia Lymphoma Foundation

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Neha Mehta-Shah, M.D. · Washington University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297697 on ClinicalTrials.gov