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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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ClinicalTrials.gov Identifier: NCT01516580
Recruitment Status : Unknown
Verified June 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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).

Condition or disease Intervention/treatment Phase
B-cell Non Hodgkin Lymphoma Mature B-cell Leukemia Burkitt-type Drug: Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C Drug: Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : June 13, 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LMB chemo

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: 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.
Experimental: LMB chemo + Rituximab
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).
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Event free survival [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
    Overall survival

  2. Acute toxicity [ Time Frame: 6 months ]
    Acute toxicity during treatment according to NCI-CTC V4

  3. Long term toxicity [ Time Frame: 5 years ]
    Long term toxicity, especially immune reconstitution, cardiac toxicity


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516580


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Canada
Children Oncology Group Operations centres
Monrovia, Canada
China
The University of Hong Kong (Clinical Trials Centre)
Hong-Kong, China
France
Institut de Cancérologie Gustave roussy
Villejuif, France, 94805
Hungary
2nd Dept. of Pediatrics Semmelweis Univ.
Budapest, Hungary, 1094
Italy
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Padova, Italy, 35128
Netherlands
Emma Children's Hospital
Amsterdam, Netherlands, 1105 AZ
Poland
Rectorat of Medical University
Wroclaw, Poland
Spain
Sociedad Española de Hematología y Oncología Pediátricas
Valencia, Spain, 46010
United Kingdom
University of Birmingham
Birmingham, United Kingdom
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Children's Oncology Group
Investigators
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Study Chair: Véronique MINARD, MD Institut Gustave Roussy, Villejuif, FRANCE
Study Chair: Thomas GROSS, MD Children Oncology Group, USA
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01516580    
Other Study ID Numbers: Inter B-NHL Ritux 2010 Phase 3
2010-019224-31 ( EudraCT Number )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Leukemia, Lymphoid
Chronic Disease
 Disease Attributes
Pathologic Processes
Cytarabine
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents