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B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescents
EU CTIS ID: 2023-505509-18-00
What this study is testing
Analyzing in pediatric patients (pts) the event-free survival (EFS) in pts with very limited B-NHL (R1 and R2 stage I and II) substituting anthracyclines by the rituximab window (R) without compromising survival rates. the EFS in pts with limited B-NHL (R2 stage III) randomly assigned to receive R plus standard chemotherapy (S-CTX) or S-CTX without R. the EFS and the immune reconstitution (recovery of CD19+ B-cells, IR) in pts with advanced B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type CTX and randomly assigned schedules of one versus seven doses rituximab. One dose rituximab = R plus S-CTX. Seven doses rituximab = R plus S-CTX with additional six doses of rituximab added to the first four courses of CTX. It will be tested whether EFS can be improved by adding rituximab and whether one dose rituximab is sufficient to achieve the intended improvement of EFS. In addition, the IR will be analyzed comparing the effect of the two regimens of rituximab added to S-CTX.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification. For rare subtypes (e.g. primary mediastinal large BNHL, PMLBL double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended
- availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
- age at diagnosis < 18 years
- diagnostics and treatment in one of the participating centers of the trial
- no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
- adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma Infiltration. Please contact the study center in case of unclear cases
You likely can't join if
- patients with insufficient work up not allowing a correct stratification into the risk groups
- B-cell neoplasia as second malignancy
- any other medical, psychiatric, or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
- participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
- overt hepatitis B or history of hepatitis B
- hypersensitivity to rituximab or to murine proteins, or to any of the other excipients of the Investigational Medicinal Product or to ingredients of other IMPs
See the full eligibility criteria
- newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification. For rare subtypes (e.g. primary mediastinal large BNHL, PMLBL double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended
- availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
- age at diagnosis < 18 years
- diagnostics and treatment in one of the participating centers of the trial
- no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
- adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma Infiltration. Please contact the study center in case of unclear cases
- signed informed consent of patient and or parents/guardians for treatment according to the protocol, participation and transfer of data
- follow-up of at least two years after initial diagnosis is expected
- certificate of vaccination against hepatitis B or negative serology, defined as - evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or - negative hepatitis B serology with HBs-antigen negative, anti- HBs and anti-HBc negative E.
- patients with insufficient work up not allowing a correct stratification into the risk groups
- B-cell neoplasia as second malignancy
- any other medical, psychiatric, or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
- participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
- overt hepatitis B or history of hepatitis B
- hypersensitivity to rituximab or to murine proteins, or to any of the other excipients of the Investigational Medicinal Product or to ingredients of other IMPs
- lack of CD20 expression of the lymphoma cells
- pregnancy and lactation
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.