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Mature B-cell Non-Hodgkin LymphomaPhase 2/3B-NHLNCT07168980

Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents

A Phase 2/3 study testing Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone, Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone and Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone in people with Mature B-cell Non-Hodgkin Lymphoma, run by Children's Cancer Group, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Mature B-cell Non-Hodgkin Lymphoma
What is being tested?
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone, Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone and Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteChina
Study dates
1 Jul 2025to 30 Jun 2030
Phase
Phase 2/3
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

  • Histology or cytologically confirmed mature B-cell NHL/AL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)
  • Able to comply with scheduled follow-up and with management of toxicity
  • Signed informed consent

Who cannot join

  • Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
  • Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
  • Evidence of pregnancy or lactation period. Past or current anti-cancer treatment except corticosteroids during less than one week.
  • Tumor cell negative for CD20
  • Prior exposure to rituximab
  • Hepatitis B carrier status history of HBV or positive serology.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi-jin Gao contact

+82064 86-21-38626161

gaoyijin@scmc.com.cn

China1 site, 1 recruiting

  • Shanghai Children's Medical Center

    Shanghai, Shanghai Municipality, 201315

    Recruiting

Other trials in China

About this study

Official title: Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents

The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.

Read the detailed description

In our previous study (CCCG-BNHL-2015), four-year EFS was 88.3%, mostly owing to the use of Rituximab. However, four-year EFS was only 73% for group R4. And three-year EFS was even lower, 61% for stage IV and B-AL with LDH≥4ULN. To improve survival for pediatric patients with high risk B-NHL, the investigators launched a new study in China. In this study (CCCG-BNHL-2025), patients with stage III and LDH≥2ULN, any stage IV, and B-AL will be stratified into group R4. Six injections of Rituximab will be used for patients in R4, compared with four injections in CCCG-BNHL-2015. And two injections of Rituximab will be used in the first and second cycles of chemotherapies. The first cycle of chemotherapy will be changed into AA, instead of A. For patients with stage IV (including B-AL) with LDH≥ 4ULN, two cycles of chemotherapies(AA and BB) will be added. Our aim is to test whether intensive chemotherapies with early, adequate, and intensive use of Rituximab will improve the EFS and OS of children and adolescents with highly aggressive B-NHL.

Being tested
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone, Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone, Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone, Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone, Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
Keywords
mature B-cell non-Hodgkin lymphoma, children, adolescent, rituximab

What participants receive

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

  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, PrednisoneDrug

    Also called Protocol A

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1;

  • Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, PrednisoneDrug

    Ifosphamide 1.2g/m2, D1~5; Etoposide, 60mg/m2, D3~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1;

  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, PrednisoneDrug

    Also called Protocol A

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;

  • Ifosphamide, Etoposide, Methotrexate, Vincristine, PrednisoneDrug

    Also called Protocol B

    Ifosphamide 1.2g/m2, D1~5; Etoposide, 60mg/m2, D3~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1

  • Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, PrednisoneDrug

    Also called Protocol AA

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4; Vindelsine 3mg/m2 (MAX 5mg), D1; Cytarabine 2g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,4(CNS2-3),8

  • Ifosphamide, Etoposide, Methotrexate, Vindelsine, PrednisoneDrug

    Also called Protocol BB

    Ifosphamide 1.2g/m2, D1~5; Etoposide, 100mg/m2, D3~5; Methotrexate, 5g/m2, D1;Vindelsine 3mg/m2 (MAX 5mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8

  • Prednisone,Vincristine, CyclophosphamideDrug

    Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1

Study groups in NCT07168980
Study groupRoleWhat they receive
Risk group 1OtherComplete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Receives: Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone; Drug: Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Risk group 2OtherNot or incompletely resected stage I/II disease and LDH <2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Receives: Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone; Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Risk group 3OtherStage III with LDH < 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
Receives: Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone; Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone; Drug: Prednisone,Vincristine, Cyclophosphamide
Risk group 4OtherStage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
Receives: Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone; Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone; Drug: Prednisone,Vincristine, Cyclophosphamide

What is being measured

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

  1. Event free survival

    Measured: 3 years

Secondary outcomes (1)

  1. Overall survival

    Measured: 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 Sep 2025
  2. Study start1 Jul 2025
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Arms and Interventions
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168980
Sponsor's protocol ID
CCCG-BNHL-2025
Acronym
B-NHL
Status last verified
Jun 2026
First submitted
4 Sep 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Dong J, Xu Z, Guo X, Ye F, Fan C, Gao J, Gao Y, Yang L. Effect of rituximab on immune status in children with aggressive mature B-cell lymphoma/leukemia-a prospective study from CCCG-BNHL-2015. Heliyon. 2024 Mar 5;10(5):e27305. doi: 10.1016/j.heliyon.2024.e27305. eCollection 2024 Mar 15.

    PubMed 38495131

  • Zhao J, Liu TF, Wu KF, Yang LC, Xu XJ, Lu J, Shao JB, Li F, Ma FT, Guo X, Li H, Liu AG, Wang NL, Shen HP, Li Y, Liu SX, Liang CD, Shen SH, Fang YJ, Gao YJ. Clinical and molecular characteristics of paediatric mature B-cell acute lymphocytic leukaemia and non-Hodgkin lymphoma with bone marrow involvement: A joint study between the CCCG leukaemia and lymphoma groups. Br J Haematol. 2025 Apr;206(4):1149-1159. doi: 10.1111/bjh.20011. Epub 2025 Feb 17.

    PubMed 39962993

  • Wang X, Ding L, Fang Y, Yan J, Gao J, Yang L, Liu A, Lu J, Wang J, Zhang A, Gao Y, Ju X. The Prognostic and Risk Factors for Children With High-Risk Mature B-Cell Non-Hodgkin's Lymphoma: A Retrospective Multicenter Study. Cancer Med. 2024 Nov;13(21):e70309. doi: 10.1002/cam4.70309.

    PubMed 39513286

  • Minard-Colin V, Auperin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children's Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. doi: 10.1056/NEJMoa1915315.

    PubMed 32492302

  • Gao YJ, Fang YJ, Gao J, Yan J, Yang LC, Liu AG, Ju XL, Lu J, Han YL, Wang J, Xie M, Guo X, Tang JY. A prospective multicenter study investigating rituximab combined with intensive chemotherapy in newly diagnosed pediatric patients with aggressive mature B cell non-Hodgkin lymphoma (CCCG-BNHL-2015): a report from the Chinese Children's Cancer Group. Ann Hematol. 2022 Sep;101(9):2035-2043. doi: 10.1007/s00277-022-04904-w. Epub 2022 Jul 13.

    PubMed 35829780

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone, Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone and Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone in people with Mature B-cell Non-Hodgkin 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 6 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: looking for participants now, as of the sponsor's last update on 4 Jun 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Yi-jin Gao (+82064 86-21-38626161, gaoyijin@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (time frame: 3 years). 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 NCT07168980, which also lists 5 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 4 Jun 2026.

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