NCT03971318

Brief Summary

With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 5, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

May 30, 2019

Last Update Submit

May 5, 2022

Conditions

Lymphoma, Non-HodgkinLymphoblastic Lymphoma, ChildhoodPTEN LossNOTCH1 Gene MutationPediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • Event-free survival (EFS)

    EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies.

    through study completion, maximal eight years

Secondary Outcomes (4)

  • Overall survival (OS)

    through study completion, maximal eight years

  • Relapse-free survival (RFS)

    through study completion, maximal eight years

  • Response rate (RR)

    on an average 3 weeks after finish of treatment

  • Adverse event rate

    through study completion, maximal eight years

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

lymphoblastic lymphoma patients#age at diagnosis \< 18 years old

You may qualify if:

  • Age \< 18 years old
  • Pathologically confirmed lymphoblastic lymphoma
  • Newly diagnosed patients
  • Informed consent of guardian of children patients -

You may not qualify if:

  • Age \> 18 years old
  • Recurrent lymphoblastic lymphoma
  • Secondary immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

  • Bonn BR, Rohde M, Zimmermann M, Krieger D, Oschlies I, Niggli F, Wrobel G, Attarbaschi A, Escherich G, Klapper W, Reiter A, Burkhardt B. Incidence and prognostic relevance of genetic variations in T-cell lymphoblastic lymphoma in childhood and adolescence. Blood. 2013 Apr 18;121(16):3153-60. doi: 10.1182/blood-2012-12-474148. Epub 2013 Feb 8.

    PMID: 23396305BACKGROUND

  • Callens C, Baleydier F, Lengline E, Ben Abdelali R, Petit A, Villarese P, Cieslak A, Minard-Colin V, Rullier A, Moreau A, Baruchel A, Schmitt C, Asnafi V, Bertrand Y, Macintyre E. Clinical impact of NOTCH1 and/or FBXW7 mutations, FLASH deletion, and TCR status in pediatric T-cell lymphoblastic lymphoma. J Clin Oncol. 2012 Jun 1;30(16):1966-73. doi: 10.1200/JCO.2011.39.7661. Epub 2012 Apr 30.

    PMID: 22547598RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic Diseases

Study Officials

  • Zhen zijun

    Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Zhen zijun

CONTACT

13609712260zhenzj@sysucc.org.cn

Sun xiaofei

CONTACT

13600099837sunxf@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

May 5, 2017

Primary Completion

May 5, 2022

Study Completion

May 5, 2025

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)