search
Back to results

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

Primary Purpose

Primary Mediastinal Large B Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Mediastinal Large B Cell Lymphoma

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University Hospitals Leuven
  • Children Oncology Group Operations centres
  • Gustave Roussy
  • 2nd Dept. of Pediatrics Semmelweis Univ.
  • Associazione Italiana di Ematologia ed Oncologia Pediatrica
  • Emma Children's Hospital
  • Rectorat of Medical University
  • Sociedad Española de Hematología y Oncología Pediátricas
  • University of Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DA-EPOCH-R

Arm Description

6 courses of Dose Adjusted-EPOCH-Rituximab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survival
Overall survival
Acute toxicity
Acute toxicity during treatment according to NCI-CTC V4
Long term toxicity
Long term toxicity, especially immune reconstitution, cardiac toxicity

Full Information

First Posted
January 19, 2012
Last Updated
March 17, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Children's Oncology Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01516567
Brief Title
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Children's Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Mediastinal Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DA-EPOCH-R
Arm Type
Experimental
Arm Description
6 courses of Dose Adjusted-EPOCH-Rituximab
Intervention Type
Drug
Intervention Name(s)
Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Intervention Description
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
Primary Outcome Measure Information:
Title
Event free survival
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Survival
Description
Overall survival
Time Frame
5 years
Title
Acute toxicity
Description
Acute toxicity during treatment according to NCI-CTC V4
Time Frame
6 months
Title
Long term toxicity
Description
Long term toxicity, especially immune reconstitution, cardiac toxicity
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine PATTE, MD
Organizational Affiliation
Institut Gustave Roussy, Villejuif, FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas GROSS, MD
Organizational Affiliation
Children's Oncology Group, USA
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Children Oncology Group Operations centres
City
Monrovia
Country
Canada
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
2nd Dept. of Pediatrics Semmelweis Univ.
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Associazione Italiana di Ematologia ed Oncologia Pediatrica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Emma Children's Hospital
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Rectorat of Medical University
City
Wroclaw
Country
Poland
Facility Name
Sociedad Española de Hematología y Oncología Pediátricas
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
University of Birmingham
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34570655
Citation
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.
Results Reference
derived
Links:
URL
http://www.igr.fr
Description
Institute Gustave Roussy web site

Learn more about this trial

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

We'll reach out to this number within 24 hrs