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NCT Number: NCT03297697

Minimal Residual Disease in Peripheral T-cell Lymphoma

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.

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Key information

Conditions

Peripheral T Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age.
  • Histologically-confirmed peripheral T-cell lymphoma being treated with curative intent. Eligible histologies include, but are not limited to: peripheral T-cell lymphoma, not otherwise specified; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma, ALK negative; and anaplastic large cell lymphoma, ALK positive.
  • Plan for treatment with frontline multi-agent anthracycline containing chemotherapy for curative intent (for example, CHOP, CHOEP, EPOCH). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
  • 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

  • Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion criteria

  • Receiving second line of therapy or greater.
  • Diagnosis of primary cutaneous T-cell lymphoma, extranodal NK-cell lymphoma, acute T-cell lymphoma/leukemia, hepatosplenic T-cell lymphoma.

Treatment and study plan

Tumor Biopsy

Procedure

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

Peripheral blood draw

Procedure

-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

Lymphotrack TCR clonality assay

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen

    Time frame: Baseline

  4. Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment

    Time frame: Through 2 years

  5. Rate of decline of the tumor specific sequence or sequences predict duration of response

    Time frame: Through 2 years

  6. Characterize the lead time from MRD positivity to subsequent clinical relapse

    Time frame: Through 2 years

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Invivoscribe, Inc.
  • National Cancer Institute (NCI)
  • T-Cell Leukemia Lymphoma Foundation

Registry information

Official study title

A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2017
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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