Minimal Residual Disease in Peripheral T-cell Lymphoma

Completed

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Procedure: Tumor biopsy; Procedure: Peripheral blood draw; Procedure: Lymphotrack TCR clonality assay

• Registration Number: NCT03297697
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1: Lymphotrack	Peripheral blood draw	-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.
Arm 1: Lymphotrack	Lymphotrack TCR clonality assay	-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.
Arm 1: Lymphotrack	Tumor biopsy	-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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of decline of the tumor specific sequence or sequences predict duration of response	Through 2 years
Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen	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
Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment	Through 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
Characterize the lead time from MRD positivity to subsequent clinical relapse	Through 2 years

Trial Locations

Locations (3)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States