Status:
UNKNOWN
Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Children's Oncology Group
Conditions:
B-cell Non Hodgkin Lymphoma
Mature B-cell Leukemia Burkitt-type
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT01516580
Start Date
December 1 2011
End Date
December 1 2021
Last Update
June 14 2017
Active Locations (10)
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1
University Hospitals Leuven
Leuven, Belgium, 3000
2
Children Oncology Group Operations centres
Monrovia, Canada
3
The University of Hong Kong (Clinical Trials Centre)
Hong Kong, China
4
Institut de Cancérologie Gustave roussy
Villejuif, France, 94805