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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01516567

Collaborator

Children's Oncology Group (Other)

Enrollment

Locations

Arm

116

Anticipated Duration (Months)

5.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Mediastinal Large B Cell Lymphoma	Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DA-EPOCH-R 6 courses of Dose Adjusted-EPOCH-Rituximab	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.

Arm

Intervention/Treatment

Experimental: DA-EPOCH-R

6 courses of Dose Adjusted-EPOCH-Rituximab

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.

Outcome Measures

Primary Outcome Measures

Event free survival [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 Outcome Measures

Survival [5 years]
Overall survival
Acute toxicity [6 months]
Acute toxicity during treatment according to NCI-CTC V4
Long term toxicity [5 years]
Long term toxicity, especially immune reconstitution, cardiac toxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospitals Leuven	Leuven	Belgium	3000
2	Children Oncology Group Operations centres	Monrovia	Canada
3	Gustave Roussy	Villejuif	France	94805
4	2nd Dept. of Pediatrics Semmelweis Univ.	Budapest	Hungary	1094
5	Associazione Italiana di Ematologia ed Oncologia Pediatrica	Padova	Italy	35128
6	Emma Children's Hospital	Amsterdam	Netherlands	1105 AZ
7	Rectorat of Medical University	Wroclaw	Poland
8	Sociedad Española de Hematología y Oncología Pediátricas	Valencia	Spain	46010
9	University of Birmingham	Birmingham	United Kingdom