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

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT03620578
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DA-EPOCH-R followed by Nivolumab — DRUG
    5 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

Study Details

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.

Key Dates

Start date
Aug 1, 2018
Status verified
Feb 2024
Primary completion
Jan 30, 2024
Completion
Oct 31, 2026

Study Design

Enrollment
97 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DA-EPOCH-R followed by Nivolumab
    5 cycles of DA-EPOCH-R protocol induction, followed with one year Nivolumab consolidation for end-of-induction patients who are in complete metabolic response

Primary Outcome Measure

12 months DFS from Nivolumab consolidation registration [ Time Frame: 12 months ]

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