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Minimal Residual Disease in Peripheral T-cell Lymphoma

This study is currently recruiting participants.
Verified September 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03297697
First Posted: September 29, 2017
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Invivoscribe
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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 from T-cell lymphoma. 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 Intervention
Peripheral T Cell Lymphoma Procedure: Tumor biopsy Procedure: Peripheral blood draw Device: Lymphotrack TCR clonality assay

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Feasibility of Lympotrack 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:
  • Feasibility of Lympotrack 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 ]

Estimated Enrollment: 42
Actual Study Start Date: July 31, 2017
Estimated Study Completion Date: July 31, 2021
Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Lymphotrack
-Patients will be treated with frontline chemotherapy per the treating physician's discretion. The intervention in this study will involve 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.
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
Device: Lymphotrack TCR clonality assay
-Assay with high sensitivity that can be performed with peripheral blood

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Histologically-confirmed peripheral T-cell lymphoma being treated with curative intent. Eligible histologies include: 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 to identify the tumor-specific clonotype if tissue is not available at time of enrollment.
  • 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.
  Contacts and Locations
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
Contact: Neha Mehta-Shah, M.D. 314-273-1070 mehta-n@wustl.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Not yet 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 Not yet 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
Investigators
Study Chair: Neha Mehta-Shah, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03297697     History of Changes
Other Study ID Numbers: 201706050
First Submitted: September 26, 2017
First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes