Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Overview[ - collapse ][ - ]
| 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. |
|---|---|
| Condition | Primary Mediastinal Large B Cell Lymphoma |
| Intervention | Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab |
| Phase | Phase 2 |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris |
| ClinicalTrials.gov Identifier | NCT01516567 |
| First Received | January 19, 2012 |
| Last Updated | November 25, 2013 |
| Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 19, 2012 |
|---|---|
| Last Updated Date | November 25, 2013 |
| Start Date | December 2011 |
| Estimated Primary Completion Date | December 2021 |
| Current Primary Outcome Measures | Event free survival [Time Frame: 36 months] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| 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 |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | 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. |
| Study Arm (s) | Experimental: DA-EPOCH-R 6 courses of Dose Adjusted-EPOCH-Rituximab |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | December 2021 |
| Estimated Primary Completion Date | June 2019 |
| 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. |
| Gender | Both |
| Ages | 6 Months |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Catherine PATTE, MD 33 1 42 11 41 76 catherine.patte@igr.fr |
| Location Countries | Belgium, France, Hungary, Italy, Netherlands, Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01516567 |
|---|---|
| Other Study ID Numbers | Inter B-NHL Ritux 2010 Phase 2 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Gustave Roussy, Cancer Campus, Grand Paris |
| Study Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Collaborators | Children's Oncology Group |
| Investigators | Study Chair: Catherine PATTE, MD Institut Gustave Roussy, Villejuif, FRANCEStudy Chair: Thomas GROSS, MD Children's Oncology Group, USA |
| Verification Date | November 2013 |
Locations[ + expand ][ + ]
| University Hospitals Leuven | Leuven, Belgium, 3000 Active, not recruiting |
|---|---|
| Gustave Roussy | Villejuif, France, 94805 Contact: Catherine Patte, MD | 0142114176+33 | catherine.patte@igr.frPrincipal Investigator: Catherine Patte, MD Recruiting |
| 2nd Dept. of Pediatrics Semmelweis Univ. | Budapest, Hungary, 1094 Active, not recruiting |
| Associazione Italiana di Ematologia ed Oncologia Pediatrica | Padova, Italy, 35128 Contact: Angelo Roselo, MD | + 39 049 821 3579 | angelo.rosolen@unipd.itPrincipal Investigator: Angelo Roselo, MD Recruiting |
| Emma Children's Hospital | Amsterdam, Netherlands, 1105 AZ Active, not recruiting |
| Sociedad Española de Hematología y Oncología Pediátricas | Valencia, Spain, 46010 Active, not recruiting |