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Minimal Residual Disease in Peripheral T-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03297697
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Invivoscribe
National Cancer Institute (NCI)
T-Cell Leukemia Lymphoma Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peripheral T Cell Lymphoma Procedure: Tumor biopsy Procedure: Peripheral blood draw Procedure: Lymphotrack TCR clonality assay

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

Procedure: 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

Procedure: Lymphotrack TCR clonality assay
-Assay with high sensitivity that can be performed with peripheral blood




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood, bone marrow, and tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with peripheral T cell lymphoma who are seen in clinics associated with the participating locations
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297697


Contacts
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Contact: Neha Mehta-Shah, M.D. 314-273-1070 mehta-n@wustl.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Eric D Jacobsen, M.D.    617-582-9086    eric_jacobsen@dfci.harvard.edu   
Principal Investigator: Eric D Jacobsen, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Neha Mehta-Shah, M.D.    314-273-1070    mehta-n@wustl.edu   
Principal Investigator: Neha Mehta-Shah, M.D.         
Sub-Investigator: Nancy Bartlett, M.D.         
Sub-Investigator: Todd Fehniger, M.D., Ph.D.         
Sub-Investigator: Amanda Cashen, M.D.         
Sub-Investigator: Brad Kahl, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Steven Horwitz, M.D.    212-639-3045      
Principal Investigator: Steven Horwitz, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Invivoscribe
National Cancer Institute (NCI)
T-Cell Leukemia Lymphoma Foundation
Investigators
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Study Chair: Neha Mehta-Shah, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03297697     History of Changes
Other Study ID Numbers: 201706050
5K12CA167540-07 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Neoplastic Processes
Pathologic Processes