Clinical trial NCT05978141: A Registry for People With T-cell Lymphoma
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: 23-190
T-cell lymphoma
Memorial Sloan Kettering Cancer Center
T-cell Lymphoma Master Repository
TCLMR
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants populating the T-cell Lymphoma Master Repository/TCLMR
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Cancer Center (Data collection only)
state: California
city: San Diego
country: United States
facility: UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (Data collection only)
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center (Data collection only)
state: California
city: Aurora
country: United States
facility: University of Colorado (Data Collection Only)
state: Colorado
city: New Haven
country: United States
facility: Yale University (Data Collection Only)
state: Connecticut
city: Miami
country: United States
facility: University of Miami (Data Collection Only)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center (Data Collection Only)
state: Florida
city: Atlanta
country: United States
facility: Emory University (Data Collection Only)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine (Data Collection)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital (Data Collection Only)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute (Data Collection Only)
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic (Data Collection Only)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University (Data Collection Only)
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska (Data collection only)
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (All protocol activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center (Data Collection Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
city: Columbus
country: United States
facility: Ohio State University (Data Collection Only)
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania (Data Collection Only)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital (Data collection only)
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center (Data Collection Only)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: