CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL

NCT04881838 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CCCG-ALCL-2020
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Anaplastic Large Cell Lymphoma

Keywords

Anapestic Large Cell Lymphoma; vinorelbine; pediatric; treatment outcome; Chinese

Outcome Measures

Primary Outcomes (2)

• 3-year event free survival (EFS)

  Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death

  Up to 3 years

• Treatment-related adverse events

  Number of participants with treatment-related adverse events as assessed by CTCAEv5.0

  Up to 3years

Secondary Outcomes (3)

• Patient compliance

  Up to 3years

• Value of early PET/CT in pediatric ALCL

  Up to 3 years

• Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL

  Up to 3 years

Study Arms (1)

High risk group

EXPERIMENTAL

1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement

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

Interventions

P regimen DRUG

Dexamethasone 5 mg/m2 Days 1 and 2; 10mg/m2 Day 3 to 5; Cyclophosphamide 200 mg/m2 Days 1 and 2 Intrathecal therapy Day 1

High risk group

Course B1 +Vin DRUG

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

High risk group

Course A2 + Vin DRUG

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

High risk group

Course B2 +Vin DRUG

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

High risk group

Course A3 + Vin DRUG

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

High risk group

Course B3 +Vin DRUG

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

High risk group

Maintenance therapy DRUG

Vinorelbine 25 mg/m2 IV, weekly for 3 consecutive weeks followed by 1-week rest. Totally 80 cycles.

High risk group

Course A1 + Vin DRUG

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

High risk group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Children's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Tianjin Cancer Hospital: collaborator
• West China Second University Hospital: collaborator
• Xiangya Hospital: collaborator
• Shenzhen Children's Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Children's Cancer Group, China: lead
• Shanghai Children's Medical Center: collaborator
• 1st Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

Location

Related Publications (7)

• 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.

  PMID: 32987765 RESULT

• 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.

  PMID: 32730187 RESULT

• 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.

  PMID: 32661576 RESULT

• 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.

  PMID: 20679620 RESULT

• 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.

  PMID: 19139435 RESULT

• 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.

  PMID: 28273702 RESULT

• 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.

  PMID: 28787259 RESULT

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Yijin Gao, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: All enrolled patients stratified into high risk group are assigned to one treatment regimen

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 11, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be shared within the all hospitals every 12 months after enrollment of patients.
• Access Criteria: Scheduled meeting and paper transferring.

Locations

CN (1)