- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516567
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
March 17, 2021 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- University Hospitals Leuven
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Monrovia, Canada
- Children Oncology Group Operations centres
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Villejuif, France, 94805
- Gustave Roussy
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Budapest, Hungary, 1094
- 2nd Dept. of Pediatrics Semmelweis Univ.
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Padova, Italy, 35128
- Associazione Italiana di Ematologia ed Oncologia Pediatrica
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Amsterdam, Netherlands, 1105 AZ
- Emma Children's Hospital
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Wroclaw, Poland
- Rectorat of Medical University
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Valencia, Spain, 46010
- Sociedad Española de Hematología y Oncología Pediátricas
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Birmingham, United Kingdom
- University of Birmingham
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: DA-EPOCH-R
6 courses of Dose Adjusted-EPOCH-Rituximab
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6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Event free survival
Time Frame: 36 months
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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.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Survival
Time Frame: 5 years
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Overall survival
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5 years
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Acute toxicity
Time Frame: 6 months
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Acute toxicity during treatment according to NCI-CTC V4
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6 months
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Long term toxicity
Time Frame: 5 years
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Long term toxicity, especially immune reconstitution, cardiac toxicity
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Catherine PATTE, MD, Institut Gustave Roussy, Villejuif, France
- Study Chair: Thomas GROSS, MD, Children's Oncology Group, USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2012
Primary Completion (ACTUAL)
April 1, 2017
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (ESTIMATE)
January 25, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Etoposide
- Rituximab
- Doxorubicin
- Vincristine
Other Study ID Numbers
- Inter B-NHL Ritux 2010 Phase 2
- 2010-019224-31 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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