Clinical trial · Interventional
CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL
Using a Modified ALCL99 Regimen for Chinese Children With Newly Diagnosed High-risk Anapestic Large Cell Lymphoma
NCT04881838CI-TRIAL-00105941active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective study on the efficacy of modified ALCL99 regimens in the treatment of the current Chinese pediatric and adolescent high-risk ALCL and compared with our historical data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Anaplastic Large Cell Lymphoma | Childhood Anaplastic Large Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Course A1 + Vin | Drug | — | UNRESOLVED |
| Course A2 + Vin | Drug | — | UNRESOLVED |
| Course A3 + Vin | Drug | — | UNRESOLVED |
| Course B1 +Vin | Drug | — | UNRESOLVED |
| Course B2 +Vin | Drug | — | UNRESOLVED |
| Course B3 +Vin | Drug | — | UNRESOLVED |
| Maintenance therapy | Drug | — | UNRESOLVED |
| P regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High risk group
- description
- 1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
- interventionNames
- Drug: P regimen
- Drug: Course A1 + Vin
- Drug: Course B1 +Vin
- Drug: Course A2 + Vin
- Drug: Course B2 +Vin
- Drug: Course A3 + Vin
- Drug: Course B3 +Vin
- Drug: Maintenance therapy
Primary outcomes (2)
- measure
- 3-year event free survival (EFS)
- timeFrame
- Up to 3 years
- description
- Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTMussolin L, Le Deley MC, Carraro E, Damm-Welk C, Attarbaschi A, Williams D, Burke A, Horibe K, Nakazawa A, Wrobel G, Mann G, Csoka M, Uyttebroeck A, Fernandez-Delgado Cerda RF, Beishuizen A, Mellgren K, Burkhardt B, Klapper W, Turner SD, D'Amore ESG, Lamant L, Reiter A, Woessmann W, Brugieres L, Pillon MPOBOTEIFCNL. Prognostic Factors in Childhood Anaplastic Large Cell Lymphoma: Long Term Results of the International ALCL99 Trial. Cancers (Basel). 2020 Sep 24;12(10):2747. doi: 10.3390/cancers12102747. PMID 32987765
- RESULTKnorr F, Brugieres L, Pillon M, Zimmermann M, Ruf S, Attarbaschi A, Mellgren K, Burke GAA, Uyttebroeck A, Wrobel G, Beishuizen A, Aladjidi N, Reiter A, Woessmann W; European Inter-Group for Childhood Non-Hodgkin Lymphoma. Stem Cell Transplantation and Vinblastine Monotherapy for Relapsed Pediatric Anaplastic Large Cell Lymphoma: Results of the International, Prospective ALCL-Relapse Trial. J Clin Oncol. 2020 Dec 1;38(34):3999-4009. doi: 10.1200/JCO.20.00157. Epub 2020 Jul 30. PMID 32730187
- RESULTYuan Q, He Q, Mi Q, Yin MZ, Han YL, Gao YJ. Single-drug vinorelbine as a salvage re-induction regimen for 4 consecutive pediatric patients with relapsed anaplastic large-cell lymphoma in a single children's institution. Ann Hematol. 2021 Apr;100(4):1093-1095. doi: 10.1007/s00277-020-04175-3. Epub 2020 Jul 13. No abstract available. PMID 32661576
- RESULTLe Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugieres L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. doi: 10.1200/JCO.2010.28.5999. Epub 2010 Aug 2. PMID 20679620
- RESULTBrugieres L, Le Deley MC, Rosolen A, Williams D, Horibe K, Wrobel G, Mann G, Zsiros J, Uyttebroeck A, Marky I, Lamant L, Reiter A. Impact of the methotrexate administration dose on the need for intrathecal treatment in children and adolescents with anaplastic large-cell lymphoma: results of a randomized trial of the EICNHL Group. J Clin Oncol. 2009 Feb 20;27(6):897-903. doi: 10.1200/JCO.2008.18.1487. Epub 2009 Jan 12.