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New combo therapy shows promise for kids with rare lymphoma

NCT ID NCT01516567

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a combination of chemotherapy drugs (etoposide, doxorubicin, vincristine, cyclophosphamide) plus the targeted drug rituximab in 47 children and teens with primary mediastinal large B-cell lymphoma. The goal was to see how well the regimen prevented the cancer from coming back. Researchers also tracked side effects during and after treatment.

What this could mean

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

Active substance
DA-EPOCH-Rituximab (a combination of chemotherapy drugs etoposide, doxorubicin, vincristine, cyclophosphamide, and the targeted antibody rituximab)
What this could lead to
If successful, this could point toward an effective chemotherapy regimen for children with this rare lymphoma, potentially improving survival rates.
What could go wrong
This is a small, single-arm phase 2 trial with only 47 participants, so results may not apply broadly. Chemotherapy carries risks like infection, heart damage, and long-term immune 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Apr 2012

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 proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL). * PMLBL without central nervous system (CNS) involvement. * 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 * 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, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone * PMLBL patients with CNS involvement * 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 hepatitis B virus (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.

primary mediastinal large B-cell lymphoma

As listed by the trial registrant

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

Primary mediastinal large B cell lymphoma

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

  • Gustave Roussy

    Villejuif, 94805, France

  • Rectorat of Medical University

    Wroclaw, Poland

  • Sociedad Española de Hematología y Oncología Pediátricas

    Valencia, 46010, Spain

  • University Hospitals Leuven

    Leuven, 3000, Belgium

  • University of Birmingham

    Birmingham, United Kingdom

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