NCT05978141

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jul 2023Jul 2030

Study Start

First participant enrolled

July 27, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2030

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

7 years

First QC Date

July 28, 2023

Last Update Submit

May 16, 2025

Conditions

T-cell LymphomaNK-Cell LymphomaT-cell Prolymphocytic LeukemiaT-cell Large Granular Lymphocytic LeukemiaChronic Lymphoproliferative Disorder of NK CellsAggressive NK-cell LeukemiaSystemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of ChildhoodChronic Active EBV Infection of T-and NK-Cell Type, Systemic FormHydroa Vacciniforme-Like Lymphoproliferative DisorderAdult T-cell Leukemia/LymphomaExtranodal NK/T-cell Lymphoma, Nasal TypeEnteropathy-associated T-cell LymphomaMonomorphic Epitheliotropic Intestinal T-Cell LymphomaIntestinal T-Cell Lymphoma, Not Otherwise SpecifiedIndolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal TractHepatosplenic T-cell LymphomaSubcutaneous Panniculitis-Like T-Cell LymphomaMycosis FungoidesSezary SyndromePrimary Cutaneous Anaplastic Large Cell LymphomaPrimary Cutaneous T-cell LymphomaPrimary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell LymphomaPrimary Cutaneous Acral CD8-Positive T-Cell LymphomaPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell LymphomaFollicular T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypeAnaplastic Large Cell Lymphoma, ALK-PositiveAnaplastic Large Cell Lymphoma, ALK-negativeBreast Implant-Associated Anaplastic Large Cell Lymphoma

Keywords

23-190T-cell lymphomaMemorial Sloan Kettering Cancer CenterT-cell Lymphoma Master RepositoryTCLMR

Outcome Measures

Primary Outcomes (1)

  • Number of participants populating the T-cell Lymphoma Master Repository/TCLMR

    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

Study Arms (1)

Participants with T-Cell Lymphoma

Participants with pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma

Other: Optional Blood Sample and Nail Sample

Interventions

Optional Blood Sample and Nail SampleOTHER

Participants may provide optional research blood and nail samples for biobanking and future use

Participants with T-Cell Lymphoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)
  • +17 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

City of Hope Cancer Center (Data collection only)

Duarte, California, 91010, United States

NOT YET RECRUITING

UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)

San Diego, California, 92103, United States

NOT YET RECRUITING

University of California San Francisco (Data collection only)

San Francisco, California, 94143, United States

NOT YET RECRUITING

Stanford University Medical Center (Data collection only)

Stanford, California, 94305-5408, United States

NOT YET RECRUITING

University of Colorado (Data Collection Only)

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Yale University (Data Collection Only)

New Haven, Connecticut, 06511, United States

NOT YET RECRUITING

University of Miami (Data Collection Only)

Miami, Florida, 33136, United States

NOT YET RECRUITING

Moffitt Cancer Center (Data Collection Only)

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Emory University (Data Collection Only)

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Northwestern Medicine (Data Collection)

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Massachusetts General Hospital (Data Collection Only)

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Mayo Clinic (Data Collection Only)

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Washington University (Data Collection Only)

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

University of Nebraska (Data collection only)

Omaha, Nebraska, 68198-7680, United States

NOT YET RECRUITING

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Weill Cornell Medical Center (Data Collection Only)

New York, New York, 10021, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553, United States

RECRUITING

Ohio State University (Data Collection Only)

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital (Data collection only)

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, 77030, United States

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Lymphoma, T-CellLeukemia, Prolymphocytic, T-CellLeukemia, Large Granular LymphocyticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellEnteropathy-Associated T-Cell LymphomaSubcutaneous panniculitis-like T-cell lymphomaMycosis FungoidesSezary SyndromeLymphoma, Primary Cutaneous Anaplastic Large CellLymphoma, T-Cell, CutaneousImmunoblastic LymphadenopathyLymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, ProlymphocyticLeukemia, LymphoidLeukemiaLeukemia, T-CellHematologic DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphadenopathy

Study Officials

  • Steven Horwitz, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Horwitz, MD

CONTACT

646-608-2680horwitzs@MSKCC.ORG

Alison Moskowitz, MD

CONTACT

646-608-3726moskowia@mskcc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

July 27, 2023

Primary Completion (Estimated)

July 27, 2030

Study Completion (Estimated)

July 27, 2030

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(26)