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

Study acronym: HO152
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jan 2024 to Jan 30, 2024v13
  2. Primary completion date: Oct 2023 to Jan 2024v12
  3. Primary completion date: Oct 2022 to Oct 2023v11
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 24 of 24 sitesv10 Show 1 more changeShow less
    • Site details revised at 24 of 24 sites
  5. Primary completion date: Aug 2022 to Oct 2022 Completion date: Aug 2026 to Oct 2026v9 Show 1 more changeShow less
    • Completion date: Aug 2026 to Oct 2026
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 1 to 24v8
  2. Study site revisedv7 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 24 to 1v6
  4. Enrollment target: 102 to 97 Site details revised at 6 of 24 sites · Eligibility criteria shortened, about 1 wordv5 Show 2 more changesShow less
    • Site details revised at 6 of 24 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 15 of 24 sitesv4
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2018 to Aug 1, 2018 · Site details revised at 24 of 24 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2018 to Aug 1, 2018
    • Site details revised at 24 of 24 sites
  7. Interventions: DA-EPOCH-R induction followed by nivolumab consolidation (Drug) to DA-EPOCH-R followed by Nivolumab (Drug) Eligibility criteria expanded, about 26 words · Secondary endpoints revised (7) · Study description expanded, about 25 wordsv2 Show 3 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov