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Recruiting NCT05978141

A Registry for People With T-cell Lymphoma

— Observational T-cell Lymphoma NK-Cell Lymphoma T-cell Prolymphocytic Leukemia T-cell Large Granular Lymphocytic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optional Blood Sample and Nail Sample.
Who it may be relevant to
Registry conditions: T-cell Lymphoma, NK-Cell Lymphoma, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocytic Leukemia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Number of participants populating the T-cell Lymphoma Master Repository/TCLMR [Time frame: 10 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 26 centers
  • City of Hope Cancer Center (Data collection only) — Duarte
  • UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only) — San Diego
  • University of California San Francisco (Data collection only) — San Francisco
  • Stanford University Medical Center (Data collection only) — Stanford
  • University of Colorado (Data Collection Only) — Aurora
  • Yale University (Data Collection Only) — New Haven
  • University of Miami (Data Collection Only) — Miami
  • Moffitt Cancer Center (Data Collection Only) — Tampa
  • … and 18 more centers

Identifiers

NCT: NCT05978141 · 23-190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗