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NCT05978141 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

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
See also
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Completed NCT00006473 - Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
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Completed NCT01466881 - Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma Phase 2
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Recruiting NCT04480788 - CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study Phase 1
Completed NCT01254578 - Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers Phase 1
Completed NCT01748721 - MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Completed NCT00901147 - Study of Bortezomib and Panobinostat in Treating Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or NK/T-cell Lymphoma Phase 2
Terminated NCT00101205 - Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Terminated NCT00096005 - Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00040846 - Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies Phase 2

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