Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02691351
Recruitment Status : Active, not recruiting
First Posted : February 25, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

Brief Summary:
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.

Condition or disease Intervention/treatment
Non-Hodgkin T-cell Lymphoma Other: Prospective Registry

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study
Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
non-Hodgkin T-cell Lymphoma Other: Prospective Registry

Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment

  1. Regimen
  2. Response Evaluation
  3. SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall response rate to primary treatment and salvage treatment [ Time Frame: 5 years ]
  2. Progression-free survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T-cell non-Hodgkin lymphoma
Criteria

Inclusion Criteria:

  • Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008
  • Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients
  • Age ≥19 years
  • Written informed consent

Exclusion Criteria:

  • Hodgkin lymphoma
  • non-Hodgkin B-cell lymphoma
  • Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia
  • Not understanding informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691351


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Won seog Kim, PhD Samsung Medical Center

Additional Information:

Layout table for additonal information
Responsible Party: Won Seog Kim, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02691351     History of Changes
Other Study ID Numbers: 2015-11-070
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin