A Registry for People With T-cell Lymphoma

Angioimmunoblastic T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978141
• Other study ID #: 23-190
• Status: Recruiting
• Start date: July 27, 2023
• Est. completion date: July 27, 2030

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Steven Horwitz, MD
• Phone: 646-608-2680
• Email: horwitzs[@]MSKCC.ORG
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 27, 2030
• Est. primary completion date: July 27, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult T-cell Leukemia/Lymphoma
• Aggression
• Aggressive NK-cell Leukemia
• Anaplastic Large Cell Lymphoma, ALK-negative
• Anaplastic Large Cell Lymphoma, ALK-Positive
• Angioimmunoblastic T-cell Lymphoma
• Breast Implant-Associated Anaplastic Large Cell Lymphoma
• Enteropathy-associated T-cell Lymphoma
• Epstein-Barr Virus Infections
• Extranodal NK/T-cell Lymphoma, Nasal Type
• Follicular T-Cell Lymphoma
• Hepatosplenic T-cell Lymphoma
• Leukemia
• Leukemia, Prolymphocytic
• Leukemia, Prolymphocytic, T-Cell
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, Primary Cutaneous Anaplastic Large Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Lymphoproliferative Disorders
• Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
• Mycoses
• Mycosis Fungoides
• NK-Cell Lymphoma
• Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
• Panniculitis
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Primary Cutaneous Anaplastic Large Cell Lymphoma
• Primary Cutaneous T-cell Lymphoma
• Sezary Syndrome
• Subcutaneous Panniculitis-Like T-Cell Lymphoma
• T-cell Large Granular Lymphocytic Leukemia
• T-cell Lymphoma
• T-cell Prolymphocytic Leukemia

Intervention

Other:
• Optional Blood Sample and Nail Sample
Participants may provide optional research blood and nail samples for biobanking and future use

Locations

Country	Name	City	State
United States	Emory University (Data Collection Only)	Atlanta	Georgia
United States	University of Colorado (Data Collection Only)	Aurora	Colorado
United States	Memorial Sloan Kettering at Basking Ridge (All protocol activities)	Basking Ridge	New Jersey
United States	Dana Farber Cancer Institute (Data Collection Only)	Boston	Massachusetts
United States	Massachusetts General Hospital (Data Collection Only)	Boston	Massachusetts
United States	Northwestern Medicine (Data Collection)	Chicago	Illinois
United States	Ohio State University (Data Collection Only)	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)	Commack	New York
United States	City of Hope Cancer Center (Data collection only)	Duarte	California
United States	Memorial Sloan Kettering Westchester (All protocol activities)	Harrison	New York
United States	MD Anderson Cancer Center (Data Collection Only)	Houston	Texas
United States	University of Miami (Data Collection Only)	Miami	Florida
United States	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Yale University (Data Collection Only)	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Weill Cornell Medical Center (Data Collection Only)	New York	New York
United States	University of Nebraska (Data collection only)	Omaha	Nebraska
United States	Thomas Jefferson University Hospital (Data collection only)	Philadelphia	Pennsylvania
United States	University of Pennsylvania (Data Collection Only)	Philadelphia	Pennsylvania
United States	Mayo Clinic (Data Collection Only)	Rochester	Minnesota
United States	Washington University (Data Collection Only)	Saint Louis	Missouri
United States	UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)	San Diego	California
United States	University of California San Francisco (Data collection only)	San Francisco	California
United States	Stanford University Medical Center (Data collection only)	Stanford	California
United States	Moffitt Cancer Center (Data Collection Only)	Tampa	Florida
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center