Treatment for high-risk pediatric anaplastic large cell lymphoma in China
Using a Modified ALCL99 Regimen for Chinese Children with Newly Diagnosed High-risk Anapestic Large Cell Lymphoma
PHASE3 · Children's Cancer Group, China · NCT04881838
This study is testing a new treatment plan for Chinese children and teens with high-risk anaplastic large cell lymphoma to see if it helps them live longer without their cancer coming back.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Children's Cancer Group, China (network) |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04881838 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of modified ALCL99 treatment regimens for Chinese children and adolescents diagnosed with high-risk anaplastic large cell lymphoma (ALCL). It compares the outcomes of these regimens to historical data from previous studies. The trial aims to improve event-free survival rates by utilizing vinorelbine as a frontline drug option, which has shown promise in preliminary experiences. The study involves multiple treatment courses and is designed to assess the safety and effectiveness of these interventions in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 18 years or younger with newly diagnosed, histologically confirmed high-risk anaplastic large cell lymphoma.
Not a fit: Patients with prior chemotherapy, severe infections, or a life expectancy of less than two weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment outcomes for children and adolescents with high-risk ALCL in China.
How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, particularly the ALCL99 trial, which established a standard of care for pediatric ALCL.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be ≤ 18 years at the time of diagnosis * Newly diagnosed patients with histologically confirmed high-risk anaplastic large cell lymphoma * No congenital immunodeficiency, HIV infection, or prior organ transplant Exclusion Criteria: * Patients have received prior cytotoxic chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage \> Dexamethasone 40 mg/m2 for the current diagnosis or any cancer * Patients have overwhelming infection, and a life expectancy of \< 2 weeks
Where this trial is running
Shanghai
- Shanghai Children's Medical Center — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Yijin Gao, MD — Shanghai Children's Medical Center
- Study coordinator: Qing Yuan, MD
- Email: 1832975884@qq.com
- Phone: +8613062865879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Anaplastic Large Cell Lymphoma, Anapestic Large Cell Lymphoma, vinorelbine, pediatric, treatment outcome, Chinese