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Pediatric Anaplastic Large Cell LymphomaPhase 3NCT04881838

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

A Phase 3 study testing P regimen, Course A1 + Vin and Course B1 +Vin in people with Pediatric Anaplastic Large Cell Lymphoma, run by Children's Cancer Group, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Pediatric Anaplastic Large Cell Lymphoma
What is being tested?
P regimen, Course A1 + Vin and Course B1 +Vin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Children's Medical Center

    Shanghai

Other trials in China

About this study

Official title: Using a Modified ALCL99 Regimen for Chinese Children With Newly Diagnosed High-risk Anapestic Large Cell Lymphoma

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.

Read the detailed description

Anaplastic large cell lymphoma (ALCL) accounts for 15% of pediatric and adolescent non-Hodgkin lymphomas (NHLs). In our historical study (retrospective multicenter study), the 3-year event-free survival (EFS) was 65% for 80 eligible patients treated in 10 centers between January 2009 and June 2014.

The ALCL99 trial reported a 2-year overall survival of 92% and 2-year event-free survival of 74% then become the current standard frontline treatment for pediatric ALCL. The recent long-term follow-up data from ALCL99 trial highlighted its excellent outcome. A less toxic schedule of methotrexate (MTX) 3g/m2 in a 3-hour infusion without intrathecal therapy reproduced the favorable results from previous reports of NHL-BFM90 protocol with MTX at 1g/m2 in a 3-hour infusion. Additionally, a prospective ALCL-Relapse trial by the European Inter-Group for Childhood Non-Hodgkin Lymphoma demonstrated 80% of patients with a late relapse can be cured by 24 months of vinblastine monotherapy. However, vinblastine would not be advised as a treatment option in mainland China due to its inaccessibility. A pilot experience using single-drug vinorelbine in 4 pediatric patients with relapsed ALCL with satisfactory outcome provides the rational for studying vinorelbine as a front line drug option.

Being tested
P regimen, Course A1 + Vin, Course B1 +Vin, Course A2 + Vin, Course B2 +Vin
Keywords
Anapestic Large Cell Lymphoma, vinorelbine, pediatric, treatment outcome, Chinese
Medical subject headings
Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P regimenDrug

    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

  • Course A1 + VinDrug

    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;

  • Course B1 +VinDrug

    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;

  • Course A2 + VinDrug

    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;

  • Course B2 +VinDrug

    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;

  • Course A3 + VinDrug

    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;

  • Course B3 +VinDrug

    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;

  • Maintenance therapyDrug

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

Study groups in NCT04881838
Study groupRoleWhat they receive
High risk groupExperimental1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 3 years

  2. Treatment-related adverse events

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

    Measured: Up to 3years

Secondary outcomes (3)

  1. Patient compliance

    the percentage of patients who complete the maintenance therapy of this modified ALCL99 regimens

    Measured: Up to 3years

  2. Value of early PET/CT in pediatric ALCL

    Prognostic value of early remission of PET/CT after 2 cycles of chemotherapy in pediatric ALCL

    Measured: Up to 3 years

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

    Prognostic value of peripheral blood/bone marrow NPM-ALK or ALK-variants level (qPCR) at diagnosis in pediatric ALCL

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All enrolled patients stratified into high risk group are assigned to one treatment regimen
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881838
Sponsor's protocol ID
CCCG-ALCL-2020
Status last verified
Mar 2026
First submitted
10 May 2021
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol, SAP and ICF were shared before study initiation. Patient data and the information about the process of the study will be shared within the all participants annually after enrollment patients.

Publications

  • 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.

    PubMed 32987765

  • 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.

    PubMed 32730187

  • 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.

    PubMed 32661576

  • 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.

    PubMed 20679620

  • 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.

    PubMed 19139435

  • 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.

    PubMed 28273702

  • 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.

    PubMed 28787259

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing P regimen, Course A1 + Vin and Course B1 +Vin in people with Pediatric Anaplastic Large Cell Lymphoma, run by Children's Cancer Group, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year event free survival (EFS) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881838, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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