HOVON 152 (FL)
A phase II study evaluating the effect of DA-EPOCH-R induction followed by nivolumab consolidation in patients with newly diagnosed high grade B cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements.
Study treatment
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Intervention/treatment |
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| Experimental: DA-EPOCH-R followed by Nivolumab5 cycles of DA-EPOCH-R protocol induction, followed with one year Nivolumab consolidation for end-of-induction patients who are in complete metabolic response | Drug: DA-EPOCH-R followed by Nivolumab5 induction cycles of DA-EPOCH-R protocol, for patient with Deauville imaging response criteria proven complete metabolic response followed with one year Nivolumab consolidation therapy |
Inclusion criteria
- Inclusion Criteria for DA-EPOCH-R induction:
- High-grade B-cell lymphoma, with MYC in combination with BCL2 and/or BCL6 rearrangements as assessed by fluorescence in situ hybridization (FISH) according to the WHO 2016 classification.
- Age ≥ 18 year.
- Patient started with or has received one course of full dose R-CHOP.
- WHO performance status 0-3 during or after the first R-CHOP cycle.
- Ann Arbor stage II-IV at diagnosis.
- Inclusion criteria for Nivolumab consolidation:
- Complete metabolic response on end of induction 18F-FDG PET-CT assessed with the Deauville response criteria
- Patient has completed at least R-CHOP plus four cycles of DA-EPOCH-R induction treatment
Exclusion criteria
- Exclusion Criteria for DA-EPOCH-R induction:
- All histopathological diagnoses other than DH/TH-HGBL (like testicular large B-cell lymphoma or primary mediastinal B-cell lymphoma) according to WHO 2016 classification.
- Known history of indolent lymphoma with the exception of localization of an indolent lymphoma component in the bone marrow detected during pre-treatment screening procedures.
- Exclusion criteria for Nivolumab consolidation:
- Inadequate renal function or creatinine clearance < 30 mL/min (after rehydration)
- Inadequate hepatic function: bilirubin > 3 times ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin.
- Subjects with active, known or suspected autoimmune disease
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
Participating sites
- ZNA
- University Hospital Leuven Gasthuisberg