Clinical Trial

DA-EPOCH-R Induction Followed by Nivolumab Consolidation in Newly Diagnosed MYC, BCL2 and/or BCL6 Rearranged HGBL

Study acronym: HO152
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2018-08-03; most recent amendment 2024-02-13.
Status change: Recruiting → Active, Not Recruiting 2022-03-23
Status change: Not Yet Recruiting → Recruiting 2018-08-10
Trial Details
NCT Number NCT03620578
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions Non Hodgkin Lymphoma, Lymphoma, B-Cell, High-grade B-cell Lymphoma, MYC Translocation, BCL-2 Translocation
Enrollment 97 participants
Start Date 2018-08-01
Primary Completion 2024-01-30 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2024-02-14