Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients

Extranodal NK-T-Cell Lymphoma, Nasal Type Clinical Trial

Official title:

Social Media-based Patient Education and Active Self-report on Incidence and Outcomes of Adverse Events in Natural Killer/T-cell Lymphoma (NK/TCL) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079544
• Other study ID #: XHLSG-NK-1603
• Status: Completed
• Start date: March 8, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/T-cell lymphoma, nasal type, who are treated outside of clinical trials in China.

Description:

Extranodal natural killer/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma with relatively high incidence in China. L-asparaginase based chemotherapy are widely used with Chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. However, most patients were treated out of clinical trials in China. Therefore the real incidence of adverse events and treatment outcomes are largely unknown. This study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.

• Treated with at least one cycle of L-asparaginas or Pegaspargase based chemotherapy.

• Signed Informed consent.

Exclusion Criteria:

• patients who are enrolled in any other clinical trials.

• Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.

Related Conditions & MeSH terms

• Extranodal NK-T-Cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Combination Product:
• L-Asparaginase or or Pegaspargase containing chemotherapy
Patients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase.

Locations

Country	Name	City	State
China	Lymphoma House086	Beijing	Beijing
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Rong Tao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	The overall survial time of patients will be measured since the initiation of treatment to death of any reason.	2-year
Secondary	Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Chemotherapy-related and radiotherapy-related toxicities and adverse events will be collected and graded by NCI CTCAE v4.0 criteria.	Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years
Secondary	Progression free survival	Progression free survival time is defined as the time from the initiation of treatment to the date on which disease "progresses" or the date on which the patient dies, from any cause.	2-year