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Inter-groep studie voor de behandeling van kinderen en adolescenten met een B-cel non-Hodgkin lymfoom of B-ALL: Beoordeling van de werkzaamheid en veiligheid van rituximab bij patiŽnten met een hoog risico.


- candidate number12053
- NTR NumberNTR3358
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2012
- Secondary IDs2010-019224-31 / NL37584.018.11; EudraCT / CCMO
- Public TitleInter-groep studie voor de behandeling van kinderen en adolescenten met een B-cel non-Hodgkin lymfoom of B-ALL: Beoordeling van de werkzaamheid en veiligheid van rituximab bij patiŽnten met een hoog risico.
- Scientific TitleIntergroup trial for children or adolescents with B-Cell NHL or B-AL: Evaluation of Rituximab efficacy and safety in high risk patients.
- ACRONYMInter-B-NHL ritux 2010
- hypothesisRituximab (antiCD20) in association with chemotherapy has extended the survival of adult patients with diffuse large B-cell lymphoma (DLBCL). Also in adults, there is accumulating evidence of a benefit of Rituximab for Primary mediastinal large B-cell lymphoma (PMLBL) patients.
This large randomized trial is necessary to evaluate whether rituximab can add benefit to the current chemotherapy regimen for childhood B-cell lymphoma and PMLBL.
- Healt Condition(s) or Problem(s) studiedChildhood PMLBL, Childhood B-cell lymphoma
- Inclusion criteriaChildren and adolescents aged until 18 years with untreated advanced stage B-cell NHL or B-AL.

HISTOLOGY AND STAGING DISEASE:
Phase III study:
1. 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;
2. Stage III with elevated LDH level (ďB-highĒ), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL.
Phase II study:
1. Histolo-cytologically proven PMLBL;
2. PMLBL without CNS involvement.

GENERAL CONDITIONS:
1. 6 months to less than 18 years of age at the time of consent;
2. 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.

INITIAL WORK-UP:
Complete initial work-up within 8 days prior to treatment.

OTHERS:
1. Able to comply with scheduled follow-up and with management of toxicity;
2. Signed informed consent from patients and/or their parents or legal guardians.
- Exclusion criteriaHISTOLOGY AND STAGING DISEASE:
1. Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study;
2. In phase II study (PMLBL) patients with CNS involvement are not eligible.

GENERAL CONDITIONS:
1. Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology;
2. Evidence of pregnancy or lactation period;
3. There will be no exclusion criteria based on organ function.

PRIOR THERAPY:
Past or current anti-cancer treatment except corticosteroids during less than one week.

EXCLUSION CRITERIA RELATED TO RITUXIMAB:
1. Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria);
2. Prior exposure to rituximab;
3. Severe active viral infection, especially hepatitis B. Severe infection (such as sepsis, pneumonia, etc..) should be clinically controlled at the time of randomisation. Contact the national co-investigator for further advice if necessary;
4. Hepatitis B carrier status history of HBV or positive serology.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-dec-2011
- planned closingdate1-dec-2021
- Target number of participants640
- InterventionsPatients will be randomized to standard treatment or standard treatment with Rituximab. Patients in the intervention group will receive 6 injections of rituximab to a standard LMB chemotherapy regimen. The control group will receive LMB chemotherapy alone.
- Primary outcomeEvent Free Survival.
- Secondary outcome1. Overall Survival;
2. Complete Remission Rate at the assessment time;
3. For group B patients: Response in 3 categories:
A. CR at assessment time (after CYM1);
B. Slow responder = CR at CYVE2 but not after CYM1;
C. No CR.
4. Acute (at each course) and long term toxicity;
5. Immune reconstitution.
- TimepointsToxicity will be measured during the study after each course. Interim analyses for efficacy and futility will be performed approximately after 1/3 of EFS events and yearly thereafter.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M. Mierlo, van
- CONTACT for SCIENTIFIC QUERIESDr. MD. PhD. J. Zsiros
- Sponsor/Initiator Institut Gustave Roussy
- Funding
(Source(s) of Monetary or Material Support)
Institut Gustave Roussy, Roche
- PublicationsN/A
- Brief summaryPhase III - non PMLBL patients:
Prephase (COP) for all groups followed by:
1. Group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m≤;
2. Group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m≤, in 4h in C1, in 24h in C3 (except the 1st course).

Phase II Ė PMLBL patients:
6 courses of DA-EPOCH-R.

Participating countries:
Italy, Belgium, UK, Netherlands, Hungary, Poland, Spain, France, North America and Oceani. (COG will coordinate centers localized in USA, Canada, Australia, New Zealand)
- Main changes (audit trail)
- RECORD14-mrt-2012 - 5-apr-2012


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