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A Registry for People With T-cell Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT05978141
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : December 13, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
T-cell Lymphoma NK-Cell Lymphoma T-cell Prolymphocytic Leukemia T-cell Large Granular Lymphocytic Leukemia Chronic Lymphoproliferative Disorder of NK Cells Aggressive NK-cell Leukemia Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder) Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease 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 Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract Hepatosplenic T-cell Lymphoma Subcutaneous Panniculitis-Like T-Cell Lymphoma Mycosis Fungoides Sezary Syndrome Primary Cutaneous Anaplastic Large Cell Lymphoma Primary Cutaneous T-cell Lymphoma Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma 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 Other: Optional Blood Sample and Nail Sample

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens
Actual Study Start Date : July 27, 2023
Estimated Primary Completion Date : July 27, 2030
Estimated Study Completion Date : July 27, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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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): NCT05978141


Contacts
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Contact: Steven Horwitz, MD 646-608-2680 horwitzs@MSKCC.ORG
Contact: Alison Moskowitz, MD 646-608-3726 moskowia@mskcc.org

Locations
Show Show 26 study locations
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Steven Horwitz, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05978141    
Other Study ID Numbers: 23-190
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: December 13, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
23-190
T-cell lymphoma
Memorial Sloan Kettering Cancer Center
T-cell Lymphoma Master Repository
TCLMR
Additional relevant MeSH terms:
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Mycoses
Epstein-Barr Virus Infections
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Sezary Syndrome
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Cutaneous
Lymphoma, Extranodal NK-T-Cell
Leukemia, Prolymphocytic
 Leukemia, Large Granular Lymphocytic
Leukemia, Prolymphocytic, T-Cell
Enteropathy-Associated T-Cell Lymphoma
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Lymphoproliferative Disorders
Immunoblastic Lymphadenopathy
Panniculitis
Hydroa Vacciniforme
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases