drugset / Trial / NCT04881838
CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL
Phase 3
Active not recruiting
172 enrolled
Children's Cancer Group, China
Nanjing Children's Hospital · collabQilu Hospital of Shandong University · collabShanghai Children's Medical Center · collabShenzhen Children's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe First Affiliated Hospital of Zhengzhou University · collabTianjin Cancer Hospital · collabWest China Second University Hospital · collabXiangya Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2026-03-01
- Completion
- 2029-03-01
Publications
- Results Mussolin 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.
- Results Knorr 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.
- Results Yuan 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.
- Results Le 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.
- Results Brugieres 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.
- Results Lymphoma Study Group, Subspecialty Group of Hematology, the Society of Pediatrics, Chinese Medical Association; Lymphoma Study Group, Committee of Pediatrics, Chinese Anti-Cancer Association. [Diagnosis and treatment of anaplastic large-cell lymphoma in children and adolescents: a retrospective multicenter survey study]. Zhonghua Er Ke Za Zhi. 2017 Mar 2;55(3):194-199. doi: 10.3760/cma.j.issn.0578-1310.2017.03.006. Chinese.
- Results Mosse YP, Voss SD, Lim MS, Rolland D, Minard CG, Fox E, Adamson P, Wilner K, Blaney SM, Weigel BJ. Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Children's Oncology Group Study. J Clin Oncol. 2017 Oct 1;35(28):3215-3221. doi: 10.1200/JCO.2017.73.4830. Epub 2017 Aug 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 150 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 5 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 10 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 800 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 3 g | — |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |