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Completed

NCT Number: NCT01516567

Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

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.

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Key information

Conditions

Primary Mediastinal Large B Cell Lymphoma

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab

Drug

6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Survival

    Time frame: 5 years

    Overall survival

  2. Acute toxicity

    Time frame: 6 months

    Acute toxicity during treatment according to NCI-CTC V4

  3. Long term toxicity

    Time frame: 5 years

    Long term toxicity, especially immune reconstitution, cardiac toxicity

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Children's Oncology Group

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2022
First posted
Jan 25, 2012
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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