ClinicalTrials.gov record NCT05978141
A Registry for People With T-cell Lymphoma
The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective registry that will gather clinical information and matched tumor specimens from people with T‑cell or NK‑cell lymphomas. Participation typically involves providing medical data from care and, optionally, blood and nail samples for biobanking. The registry will follow participants and store linked clinical and pathology data for up to 10 years to support research.
What it is studying. To create a linked database of clinical records and matched tumor specimens so researchers can study disease features, treatments, and outcomes in T‑cell and NK‑cell lymphomas.
What the researchers hope to learn. To develop and populate a secure database of patients with T‑cell and NK‑cell lymphomas that contains curated clinical characteristics, treatment information, outcomes, and matched pathological biospecimens for future research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Optional Blood Sample and Nail Sample
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent, participants provide clinical information and treatment/outcome data and supply a tumor specimen (either existing archival tissue or a fresh biopsy). They may optionally give blood and nail samples for biobanking and future research. The treating team will collect follow‑up data and measure response as clinically appropriate; data and specimens are stored and linked in the repository (target duration up to 10 years).
How the study is structured. An observational, prospective registry (cohort). Clinical information and pathology specimens are collected and stored; participation can include optional research blood and nail samples. Participants are followed and data curated over a target period of up to 10 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on large granular lymphocytic leukemia
Important dates
- Study start
- Jul 27, 2023
- Primary completion
- Jul 27, 2030 (estimated)
- Study completion
- Jul 27, 2030 (estimated)
- Target enrollment
- 1000 participants (estimated)
- Last updated on registry
- May 20, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Steven Horwitz, MD 📞 646-608-2680 ✉ horwitzs@MSKCC.ORG
- Alison Moskowitz, MD 📞 646-608-3726 ✉ moskowia@mskcc.org
Participating sites (26)
- City of Hope Cancer Center (Data collection only)Not Yet Recruiting
Duarte, California, 91010 · United States
- Jasmine Zain, MD · 626-359-8111
- UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)Not Yet Recruiting
San Diego, California, 92103 · United States
- Aaron Goodman, MD · 858-822-6100
- University of California San Francisco (Data collection only)Not Yet Recruiting
San Francisco, California, 94143 · United States
- Weiyun Ai, MD · 415-353-2421
- Stanford University Medical Center (Data collection only)Not Yet Recruiting
Stanford, California, 94305-5408 · United States
- Michael Khodadoust, MD · 650-725-5071
- University of Colorado (Data Collection Only)Not Yet Recruiting
Aurora, Colorado, 80045 · United States
- Bradley Haverkos, MD · 212-639-3983
- Yale University (Data Collection Only)Not Yet Recruiting
New Haven, Connecticut, 06511 · United States
- Francine Foss, MD · 203-200-4363
- University of Miami (Data Collection Only)Not Yet Recruiting
Miami, Florida, 33136 · United States
- Jonathan Schatz, MD · 305-243-5302
- Moffitt Cancer Center (Data Collection Only)Not Yet Recruiting
Tampa, Florida, 33612 · United States
- Lubomir Sokol, MD, PhD · 888-663-3488
- Emory University (Data Collection Only)Not Yet Recruiting
Atlanta, Georgia, 30322 · United States
- Pamela Allen, MD, MSc · 404-778-0519
- Northwestern Medicine (Data Collection)Not Yet Recruiting
Chicago, Illinois, 60611 · United States
- Jaehyuk Choi, MD, PhD · 312-695-8106
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- clinical trial
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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