NCT03079544

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
665

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

4.5 years

First QC Date

March 9, 2017

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall survival

    The overall survial time of patients will be measured since the initiation of treatment to death of any reason.

    2-year

Secondary Outcomes (2)

  • Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years

  • Progression free survival

    2-year

Interventions

Patients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with the diagnosis of NK/TCL treated out of clinical trials are candidators for this study.

You may qualify if:

  • 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.

You may not qualify if:

  • patients who are enrolled in any other clinical trials.
  • Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lymphoma House086

Beijing, Beijing Municipality, 100010, China

Location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Asparaginase

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Rong Tao, MD

    Xinhua hospital, Shanghai Jiao Tong University of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

March 8, 2017

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations