Minimal Residual Disease in Peripheral T-cell Lymphoma

NCT03297697 | Completed DMC

• 2 other identifiers: 2017060505K12CA167540-07
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

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

  2 years

Secondary Outcomes (6)

• 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

Study Arms (1)

Arm 1: Lymphotrack

-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

Interventions

Tumor biopsy PROCEDURE

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

Arm 1: Lymphotrack

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

Arm 1: Lymphotrack

Lymphotrack TCR clonality assay PROCEDURE

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

Arm 1: Lymphotrack

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with peripheral T cell lymphoma who are seen in clinics associated with the participating locations

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Invivoscribe, Inc.: collaborator
• National Cancer Institute (NCI): collaborator
• T-Cell Leukemia Lymphoma Foundation: collaborator

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow, and tissue

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

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

Study Officials

• Neha Mehta-Shah, M.D.

  Washington University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: July 31, 2017
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)