A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

May 5, 2022 updated by: Xiao-Fei Sun, Sun Yat-sen University

A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma

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. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. 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. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Research purpose:

  1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma.
  2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival.
  3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD.
  4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Systemic ALK-positive anaplastic large cell lymphoma patients # age at diagnosis < 18 years.

Description

Inclusion Criteria:

  1. Age < 18 years old
  2. Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
  3. Newly diagnosed patients
  4. Informed consent of guardian of children patients

Exclusion Criteria:

  1. Secondary immunodeficiency disease
  2. Second neoplasm
  3. Primary cutaneous anaplastic large cell lymphoma
  4. Recurrent and progressive patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: through study completion, maximal eight years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: from the first day of protocol defined treatment until two years after start of protocol defined treatment
Rate of patients with acute toxicity defined as grade III/IV/V AE
from the first day of protocol defined treatment until two years after start of protocol defined treatment
Overall survival (OS)
Time Frame: through study completion, maximal eight years
OS is defined as time from start of treatment/randomization up to death of any
through study completion, maximal eight years
Relapse-free survival (RFS)
Time Frame: through study completion, maximal eight years
RFS 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.
through study completion, maximal eight years
Response rate (RR)
Time Frame: on an average 3 weeks after finish of treatment
Complete response, partial remission, objective effect, stable disease or progressive disease
on an average 3 weeks after finish of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Sun Xiaofei, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Anticipated)

May 5, 2022

Study Completion (Anticipated)

May 5, 2025

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCCG-ALCL-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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