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

Trial ID or NCT#

NCT01595048

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 6 Months to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Sheri Spunt
Neyssa Marina

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Contact

Peds Hem/Onc CRAs
650-723-5535