A Registry for People With T-cell Lymphoma

December 6, 2023 updated by: Memorial Sloan Kettering Cancer Center

The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens

The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope Cancer Center (Data collection only)
        • Contact:
          • Jasmine Zain, MD
          • Phone Number: 626-359-8111
      • San Diego, California, United States, 92103
        • Not yet recruiting
        • UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)
        • Contact:
          • Aaron Goodman, MD
          • Phone Number: 858-822-6100
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • University of California San Francisco (Data collection only)
        • Contact:
          • Weiyun Ai, MD
          • Phone Number: 415-353-2421
      • Stanford, California, United States, 94305-5408
        • Not yet recruiting
        • Stanford University Medical Center (Data collection only)
        • Contact:
          • Michael Khodadoust, MD
          • Phone Number: 650-725-5071
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado (Data Collection Only)
        • Contact:
          • Bradley Haverkos, MD
          • Phone Number: 212-639-3983
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Not yet recruiting
        • Yale University (Data Collection Only)
        • Contact:
          • Francine Foss, MD
          • Phone Number: 203-200-4363
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami (Data Collection Only)
        • Contact:
          • Jonathan Schatz, MD
          • Phone Number: 305-243-5302
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center (Data Collection Only)
        • Contact:
          • Lubomir Sokol, MD, PhD
          • Phone Number: 888-663-3488
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Emory University (Data Collection Only)
        • Contact:
          • Pamela Allen, MD, MSc
          • Phone Number: 404-778-0519
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Medicine (Data Collection)
        • Contact:
          • Jaehyuk Choi, MD, PhD
          • Phone Number: 312-695-8106
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital (Data Collection Only)
        • Contact:
          • Salvia Jain, MD
          • Phone Number: 857-392-4495
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Dana Farber Cancer Institute (Data Collection Only)
        • Contact:
          • Eric D Jacobsen, MD
          • Phone Number: 877-442-3324
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic (Data Collection Only)
        • Contact:
          • Nora Bennani, MD
          • Phone Number: 507-284-2511
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University (Data Collection Only)
        • Contact:
          • Neha Mehta-Shah, MD, MSCI
          • Phone Number: 314-747-1171
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • Not yet recruiting
        • University of Nebraska (Data collection only)
        • Contact:
          • Matthew Lunning, DO, FACP
          • Phone Number: 402-559-4000
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Weill Cornell Medical Center (Data Collection Only)
        • Contact:
          • Jia Ruan, MD, PhD
          • Phone Number: 646-962-2064
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 646-608-2680
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Ohio State University (Data Collection Only)
        • Contact:
          • John Reneau, MD, PhD
          • Phone Number: 614-293-8000
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania (Data Collection Only)
        • Contact:
          • Stefan Barta, MD, MS, MRCPCUK
          • Phone Number: (215) 316-5151
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Thomas Jefferson University Hospital (Data collection only)
        • Contact:
          • Pierluigi Porcu, MD
          • Phone Number: 215-955-8874
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • MD ANDERSON CANCER CENTER (Data Collection Only)
        • Contact:
          • Swami Iyer, MD
          • Phone Number: 713-352-2952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants at Memorial Sloan Kettering Cancer Center (MSKCC) will be recruited through the Lymphoma service in the Department of Medicine and the Department of Pediatrics. Participants will be recruited at the participating centers.

Description

Inclusion Criteria:

  • Written informed consent
  • Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.

  • Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):

    • T-cell prolymphocytic leukemia
    • T-cell large granular lymphocytic leukemia
    • Chronic lymphoproliferative disorder of NK cells
    • Aggressive NK-cell leukemia
    • Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood
    • Chronic active EBV infection of T- and NK-cell type, systemic form
    • Hydroa vacciniforme-like lymphoproliferative disorder
    • Adult T-cell leukemia/lymphoma
    • Extranodal NK/T-cell lymphoma, nasal type
    • Enteropathy-associated T-cell lymphoma
    • Monomorphic epitheliotropic intestinal T-cell lymphoma
    • Intestinal T-cell lymphoma, not otherwise specified (NOS)
    • Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract
    • Hepatosplenic T-cell lymphoma
    • Subcutaneous panniculitis-like T-cell lymphoma
    • Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)
    • Sézary syndrome
    • Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)
    • Primary cutaneous Gamma-Delta T-cell lymphoma
    • Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
    • Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)
    • Peripheral T-cell lymphoma, not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Follicular T-cell lymphoma
    • Nodal peripheral T-cell lymphoma with TFH phenotype
    • Anaplastic large cell lymphoma, ALK-positive
    • Anaplastic large cell lymphoma, ALK-negative
    • Breast-implant associated anaplastic large cell lymphoma.
  • NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.

Exclusion Criteria:

  • Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.
  • Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with T-Cell Lymphoma
Participants with pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma
Other: Optional Blood Sample and Nail Sample
Participants may provide optional research blood and nail samples for biobanking and future use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants populating the T-cell Lymphoma Master Repository/TCLMR
Time Frame: 10 years
To develop and populate a secure database comprised of patients with T-cell lymphomas with curated clinical characteristics and treatment outcomes matched to pathological biospecimens.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

July 27, 2030

Study Completion (Estimated)

July 27, 2030

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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