Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma

Lymphoid Neoplasm Clinical Trial

Official title:

Target Gene Sequencing for Advanced Stage, Relapsed/Refractory Natural Killer/T-cell Lymphoma and the Correlation Between Gene Abmormalities and Chemotherapy Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509804
• Other study ID #: GeneNKT
• Status: Completed
• Start date: May 10, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;

2. stage III/IV disease; or relapsed or refractory disease after at least one line prior teratment;

3. age = 18 years;

4. ECOG performance status 0-2;

5. at least one measurable lesion;

6. adequate hematological, hepatic, and renal functions;

7. life expectancy of more than 3 months.

Exclusion Criteria:

1. Previously untreated stage I/II disease;

2. with no adequate tumour tissue;

3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Related Conditions & MeSH terms

• Lymphoid Neoplasm
• Lymphoma, T-Cell

Intervention

Other:
• non-interventional
non-interventional

Locations

Country	Name	City	State
China	Mei Dong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance	The concordance of plasma cfDNA genotyping and tumor genotyping is defined as the ratio of gene variants detected in tumor and cfDNA to variants identified in tumor	2 years