Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02840747
Other study ID # AAAQ8751
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2016
Est. completion date January 2025

Study information

Verified date April 2024
Source Columbia University
Contact Larisa J. Geskin, MD
Email ljg2145@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.


Description:

CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations. Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy. - Patients with Se´zary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) =1000/µL Se´zary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio =10; (3) CD4+cluster of differentiation 7 (CD7)- cells =40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells =30 percent. - Ability to understand and willing to sign a willing informed consent document. - Age = 18 years. Inclusion Criteria for Age and Sex Matched Controls: - Matched for sex, and age +/- 10 years. - Ability to sign informed consent document. - Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents. Exclusion Criteria: - Patients with a history of previous lymphoma other than CTCL or SS or LYP. - Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator. - Current, viable pregnancy. - Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months. Exclusion Criteria for Age and Sex Matched Controls: - Previous history of CTCL, SS, LYP, or any lymphoma. - Previous history of Human Immunodeficiency Virus (HIV) infection. - Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months.

Study Design


Locations

Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of biological specimen collections This is a collection protocol to establish a tissue repository for samples from patients with CTCL. 2 years
See also
  Status Clinical Trial Phase
Terminated NCT03357224 - PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL) Phase 2
Completed NCT02567656 - Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma Phase 1
Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Recruiting NCT03646422 - AEDV Registry of Primary Cutaneous Lymphoma
Terminated NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
Active, not recruiting NCT04998331 - A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Active, not recruiting NCT02953301 - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Phase 2
Completed NCT01486277 - A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma Phase 2
Completed NCT01433731 - Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL) Phase 1
Completed NCT05137847 - A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Active, not recruiting NCT03902184 - IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma Phase 2
Completed NCT00896493 - Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma Phase 2
Completed NCT00211198 - Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL) Phase 4
Terminated NCT03601819 - Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders Phase 1
Withdrawn NCT03742804 - Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma Phase 2
Completed NCT02836886 - VircapSeq Virus Detection in Sézary Syndrome
Completed NCT00050999 - Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients Phase 4
Terminated NCT02323659 - Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas Phase 4
Completed NCT03192202 - AFM13 in Relapsed/Refractory Cutaneous Lymphomas Phase 1/Phase 2
Terminated NCT02811783 - Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL Phase 3