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

Primary Mediastinal Large B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01516567
• Other study ID #: Inter B-NHL Ritux 2010 Phase 2
• Secondary ID: 2010-019224-31
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2012
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Other known NCT identifiers

• NCT01595048

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: December 2021
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B Cell Lymphoma

Intervention

Drug:
• Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Canada	Children Oncology Group Operations centres	Monrovia
France	Gustave Roussy	Villejuif
Hungary	2nd Dept. of Pediatrics Semmelweis Univ.	Budapest
Italy	Associazione Italiana di Ematologia ed Oncologia Pediatrica	Padova
Netherlands	Emma Children's Hospital	Amsterdam
Poland	Rectorat of Medical University	Wroclaw
Spain	Sociedad Española de Hematología y Oncología Pediátricas	Valencia
United Kingdom	University of Birmingham	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Children's Oncology Group

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Secondary	Survival	Overall survival	5 years
Secondary	Acute toxicity	Acute toxicity during treatment according to NCI-CTC V4	6 months
Secondary	Long term toxicity	Long term toxicity, especially immune reconstitution, cardiac toxicity	5 years

External Links

•   Institute Gustave Roussy web site