Minimal Residual Disease in Peripheral T-cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297697
• Other study ID #: 201706050
• Secondary ID: 5K12CA167540-07
• Status: Completed
• Start date: July 31, 2017
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Neoplasm, Residual
• Peripheral T Cell Lymphoma

Intervention

Procedure:
• Tumor biopsy
Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load
• 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
• Lymphotrack TCR clonality assay
-Assay with high sensitivity that can be performed with peripheral blood

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Invivoscribe, Inc., National Cancer Institute (NCI), T-Cell Leukemia Lymphoma Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse		Through 2 years
Secondary	Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen		Baseline
Secondary	Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment		Through 2 years
Secondary	Rate of decline of the tumor specific sequence or sequences predict duration of response		Through 2 years
Secondary	Characterize the lead time from MRD positivity to subsequent clinical relapse		Through 2 years

External Links

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