Clinical trial NCT03297697: Minimal Residual Disease in Peripheral T-cell Lymphoma
Official title: A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Invivoscribe, Inc.
name: National Cancer Institute (NCI)
name: T-Cell Leukemia Lymphoma Foundation
First posted: 2017-09-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with peripheral T cell lymphoma who are seen in clinics associated with the participating locations

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: Baseline
measure: Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse
timeFrame: Through 2 years
measure: Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen
timeFrame: Baseline
measure: Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment
timeFrame: Through 2 years
measure: Rate of decline of the tumor specific sequence or sequences predict duration of response
timeFrame: Through 2 years
measure: Characterize the lead time from MRD positivity to subsequent clinical relapse
timeFrame: Through 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Washington University School of Medicine
name: Neha Mehta-Shah, M.D.
role: STUDY_CHAIR
References: