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 (HO152)

NCT03620578 Phase 2 ACTIVE_NOT_RECRUITING

The prognosis of patients with "high-grade B cell lymphoma with cellular myelocytomatosis (MYC) and B cell lymphoma 2 (BCL2) and/or B cell lymphoma 6 (BCL6) rearrangements" (double hit (DH)/triple hit (TH)-HGBL) with rituximab-CHOP (R-CHOP) is dismal as compared to patients with diffuse large B cell lymphoma (DLBCL) without MYC, BCL2 and/or BCL6 rearrangements. Currently, there is no other standard first line treatment for these patients. Dose Adjusted - Etoposide Prednisone Vincristine Cyclophosphamide Doxorubicin - Rituximab (DA-EPOCH-R) and nivolumab are both feasible treatments. Nivolumab may induce auto-immune reactions. DA-EPOCH-R may induce more hematological toxicity than R-CHOP. The hypothesis is that addition of nivolumab to DA-EPOCH-R will contribute to increased survival.

Details

Lead sponsor	Stichting Hemato-Oncologie voor Volwassenen Nederland
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	97
Start date	2018-08-01
Completion	2026-10

Conditions

• Non Hodgkin Lymphoma
• Lymphoma, B-Cell
• High-grade B-cell Lymphoma
• MYC Translocation
• BCL-2 Translocation

Interventions

• DA-EPOCH-R followed by Nivolumab

Primary outcomes

• 12 months DFS from Nivolumab consolidation registration — 12 months
  12 months DFS (defined as time from registration for consolidation to disease relapse or death, whichever comes first) of patients in CMR as assessed by end of DA-EPOCH-R treatment 18F-Fludeoxyglucose Positron Emission Tomography- Computed Tomography (18F-FDG PET-CT)

Countries

Belgium, Netherlands