A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
- Conditions
- MRDMDDAnaplastic LymphomaLymphoma, NonhodgkinPediatric Cancer
- Registration Number
- NCT03971305
- Lead Sponsor
- Sun Yat-sen University
- 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. 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Age < 18 years old
- Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
- Newly diagnosed patients
- Informed consent of guardian of children patients
- Secondary immunodeficiency disease
- Second neoplasm
- Primary cutaneous anaplastic large cell lymphoma
- Recurrent and progressive patients.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival (EFS) 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
- Secondary Outcome Measures
Name Time Method Relapse-free survival (RFS) 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.
Response rate (RR) on an average 3 weeks after finish of treatment Complete response, partial remission, objective effect, stable disease or progressive disease
Overall survival (OS) through study completion, maximal eight years OS is defined as time from start of treatment/randomization up to death of any
Adverse event rate 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
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China