A Registry for People With T-cell Lymphoma

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05978141
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 26
• Anticipated Duration (Months): 84
• Patients Per Site: 38.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
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; Other: Optional Nail Sample

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: Jul 27, 2023
• Anticipated Primary Completion Date: Jul 27, 2030
• Anticipated Study Completion Date: Jul 27, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of participants populating the T-cell Lymphoma Master Repository/TCLMR [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Cancer Center (Data collection only)	Duarte	California	United States	91010
2	UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)	San Diego	California	United States	92103
3	University of California San Francisco (Data collection only)	San Francisco	California	United States	94143
4	Stanford University Medical Center (Data collection only)	Stanford	California	United States	94305-5408
5	University of Colorado (Data Collection Only)	Aurora	Colorado	United States	80045
6	Yale University (Data Collection Only)	New Haven	Connecticut	United States	06511
7	University of Miami (Data Collection Only)	Miami	Florida	United States	33136
8	Moffitt Cancer Center (Data Collection Only)	Tampa	Florida	United States	33612
9	Emory University (Data Collection Only)	Atlanta	Georgia	United States	30322
10	Northwestern Medicine (Data Collection)	Chicago	Illinois	United States	60611
11	Massachusetts General Hospital (Data Collection Only)	Boston	Massachusetts	United States	02114
12	Dana Farber Cancer Institute (Data Collection Only)	Boston	Massachusetts	United States	02115
13	Mayo Clinic (Data Collection Only)	Rochester	Minnesota	United States	55905
14	Washington University (Data Collection Only)	Saint Louis	Missouri	United States	63110
15	University of Nebraska (Data collection only)	Omaha	Nebraska	United States	68198-7680
16	Memorial Sloan Kettering at Basking Ridge (All protocol activities)	Basking Ridge	New Jersey	United States	07920
17	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey	United States	07748
18	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)	Commack	New York	United States	11725
19	Memorial Sloan Kettering Westchester (All protocol activities)	Harrison	New York	United States	10604
20	Weill Cornell Medical Center (Data Collection Only)	New York	New York	United States	10021
21	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
22	Memorial Sloan Kettering Nassau (All protocol activities)	Uniondale	New York	United States	11553
23	Ohio State University (Data Collection Only)	Columbus	Ohio	United States	43210
24	University of Pennsylvania (Data Collection Only)	Philadelphia	Pennsylvania	United States	19104
25	Thomas Jefferson University Hospital (Data collection only)	Philadelphia	Pennsylvania	United States	19107
26	MD Anderson Cancer Center (Data Collection Only)	Houston	Texas	United States	77030

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05978141
• Other Study ID Numbers: 23-190
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: 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

Study Results

No Results Posted as of Aug 7, 2023