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Could a targeted antibody boost chemo for kids with aggressive blood cancer?

NCT ID NCT01516580

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding 6 doses of rituximab to standard chemotherapy improves outcomes for children and teens with advanced B-cell non-Hodgkin lymphoma or B-cell acute leukemia. The study enrolled 482 high-risk patients aged 6 months to 18 years. The goal was to see if the combination extends event-free survival compared to chemotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (a targeted antibody) added to standard chemotherapy
What this could lead to
If successful, adding rituximab to chemotherapy could help more children with aggressive B-cell cancers stay cancer-free longer.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Adding rituximab can increase infection risk and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

482 people

The number who actually took part.

Started

Dec 2011

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable. * Stage III with elevated LDH level ("B-high"), \[LDH \> twice the institutional upper limit of the adult normal values (\> Nx2)\] or any stage IV or B-AL. * 6 months to less than 18 years of age at the time of consent. * Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate. * Complete initial work-up within 8 days prior to treatment that allows definite staging. * Able to comply with scheduled follow-up and with management of toxicity. * Signed informed consent from patients and/or their parents or legal guardians Exclusion Criteria: * 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. * There will be no exclusion criteria based on organ function. * Past or current anti-cancer treatment except corticosteroids during less than one week. * Tumor cell negative for CD20 * Prior exposure to rituximab. * Severe active viral infection, especially hepatitis B. * Hepatitis B carrier status history of HBV or positive serology. * Participation in another investigational drug clinical trial. * Patients who, for any reason, are not able to comply with the national legislation.

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell acute lymphoblastic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma Burkitt lymphoma diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell non Hodgkin lymphoma Mature B-cell leukemia Burkitt-type

Contacts and locations

Locations

  • 2nd Dept. of Pediatrics Semmelweis Univ.

    Budapest, 1094, Hungary

  • Associazione Italiana di Ematologia ed Oncologia Pediatrica

    Padova, 35128, Italy

  • Children Oncology Group Operations centres

    Monrovia, Canada

  • Emma Children's Hospital

    Amsterdam, 1105 AZ, Netherlands

  • Institut de Cancérologie Gustave roussy

    Villejuif, 94805, France

  • Rectorat of Medical University

    Wroclaw, Poland

  • Sociedad Española de Hematología y Oncología Pediátricas

    Valencia, 46010, Spain

  • The University of Hong Kong (Clinical Trials Centre)

    Hong Kong, China

  • University Hospitals Leuven

    Leuven, 3000, Belgium

  • University of Birmingham

    Birmingham, United Kingdom

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