Primary Mediastinal Large B Cell LymphomaPhase 2NCT01516567
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
A Phase 2 study testing Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab in people with Primary Mediastinal Large B Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 9 sites in 9 countries.
Trial summary
Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Primary Mediastinal Large B Cell Lymphoma
- What is being tested?
- Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 9 sitesin 9 countries
- Study dates
- 1 Apr 2012to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Italy1 site
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Padova, 35128
Spain1 site
Sociedad Española de Hematología y Oncología Pediátricas
Valencia, 46010
About this study
Official title: Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL
Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.
- Being tested
- Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, RituximabDrug
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
| Study group | Role | What they receive |
|---|---|---|
| DA-EPOCH-R | Experimental | 6 courses of Dose Adjusted-EPOCH-Rituximab Receives: Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
Measured: 36 months
Secondary outcomes (3)
Survival
Overall survival
Measured: 5 years
Acute toxicity
Acute toxicity during treatment according to NCI-CTC V4
Measured: 6 months
Long term toxicity
Long term toxicity, especially immune reconstitution, cardiac toxicity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start1 Apr 2012
- Primary completionApr 2017
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Mediastinal Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Oncology Group
- Responsible party
- Sponsor
- Investigators
- Catherine PATTE, MD, Study chair, Institut Gustave Roussy, Villejuif, FRANCEThomas GROSS, MD, Study chair, Children's Oncology Group, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516567
- Sponsor's protocol ID
- Inter B-NHL Ritux 2010 Phase 2
- Other IDs
- 2010-019224-31
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2012
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.
PubMed 34570655
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL
- ClinicalTrials.gov ID
- NCT01516567
- Acronym / sponsor ID
- Inter B-NHL Ritux 2010 Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Children's Oncology Group
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DA-EPOCH-R | Experimental | Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab6 courses of Dose Adjusted-EPOCH-Rituximab |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH. | Drug | DA-EPOCH-R |
Primary outcome
Event free survival
Time frame: 36 months
Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
3 secondary outcomes
Survival
Time frame: 5 years
Acute toxicity
Time frame: 6 months
Long term toxicity
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 34570655Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.
- Institute Gustave Roussy web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine PATTE, MD study chair
Institut Gustave Roussy, Villejuif, FRANCE
Thomas GROSS, MD study chair
Children's Oncology Group, USA
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab in people with Primary Mediastinal Large B Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 9 sites in 9 countries.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Canada, France, Hungary, Italy and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Event free survival (time frame: 36 months). 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 NCT01516567, which also lists 1 linked publication.
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 9 Feb 2026.