Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients
Overview[ - collapse ][ - ]
Purpose | The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL). |
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Condition | B-cell Non Hodgkin Lymphoma Mature B-cell Leukemia Burkitt-type |
Intervention | Drug: Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C Drug: Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C |
Phase | Phase 3 |
Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris |
ClinicalTrials.gov Identifier | NCT01516580 |
First Received | January 19, 2012 |
Last Updated | November 25, 2013 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | January 19, 2012 |
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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: 24 months] [Designated as safety issue: No]Minimum time to death from any cause, presence of viable cells in residue after [2nd (Rituximab-)CYVE], relapse, progressive disease, or second malignancy measured from randomization. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients |
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Official Title | Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial |
Brief Summary | The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C Prephase (COP) for all groups followed by: in group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m² in group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses. Drug: Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE). |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 600 |
Estimated Completion Date | December 2021 |
Estimated Primary Completion Date | June 2019 |
Eligibility Criteria | Inclusion Criteria: - Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable. - Stage III with elevated LDH level ("B-high"), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL. - 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 and during five months for men, taking into account the characteristics of methotrexate. - 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, MALT and nodular marginal zone are not included into this therapeutic study - 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 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 | NCT01516580 |
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Other Study ID Numbers | Inter B-NHL Ritux 2010 Phase 3 |
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 Oncology Group, USA |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
University Hospitals Leuven | Leuven, Belgium, 3000 Contact: Anne Uyttebroeck, MD | + 32 16 34 39 72 | anne.uyttebroeck@uzleuven.bePrincipal Investigator: Anne Uyttebroeck, MD Recruiting |
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Institut de Cancérologie Gustave roussy | Villejuif, France, 94805 Contact: Catherine PATTE, MD | 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 Rosolen, MD | + 39 049 821 3579 | angelo.rosolen@unipd.itPrincipal Investigator: Angelo rosolen, MD Recruiting |
Emma Children's Hospital | Amsterdam, Netherlands, 1105 AZ Active, not recruiting |
Sociedad Española de Hematología y Oncología Pediátricas | Valencia, Spain, 46010 Contact: Rafael F Delgado, MD | + 34 96 3862624 | Rafael.Fdez-delgado@uv.esPrincipal Investigator: Rafael F Delgado, MD Recruiting |