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Clinical Trials/NCT01516567
NCT01516567
Completed
Phase 2

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

Gustave Roussy, Cancer Campus, Grand Paris9 sites in 9 countries47 target enrollmentStarted: April 1, 2012Last updated:
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ConditionsPrimary Mediastinal Large B Cell Lymphoma
InterventionsEtoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
DrugsEtoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab

Overview

Phase
Phase 2
Status
Completed
Enrollment
47
Locations
9
Primary Endpoint
Event free survival
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Months to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

DA-EPOCH-R

Experimental

6 courses of Dose Adjusted-EPOCH-Rituximab

Intervention: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab (Drug)

Outcomes

Primary Outcomes

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

  • Survival(5 years)
  • Long term toxicity(5 years)
  • Acute toxicity(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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