A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2026 → Sep 30, 2027
See other at-risk trials from BioInvent International AB

Record History

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  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised at 10 of 27 sites
    • Study description expanded, about 3 words
  2. Study sites: 22 to 27v12
  3. Primary and study completion dates: Sep 22, 2025 to Sep 30, 2026v11 Show 9 more changesShow less
    • Primary endpoints: 2 to 3
    • Enrollment target: 98 to 140
    • Interventions: BI-1206 (Biological) to Acalabrutinib (Biological), BI-1206 (Biological), Rituximab (Biological)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 6 to 4
    • Study description shortened, about 32 words
    • Study sites revised (22)
    • Study arms: 2 to 5
    • Study title expanded, about 3 words
  4. Study sites: 17 to 22v10
  5. Secondary endpoints: details revised at 1 of 6 entriesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Enrollment target: 30 to 98v8 Show 8 more changesShow less
    • Primary completion date: Mar 30, 2023 to Sep 22, 2025
    • Study sites: 9 to 17
    • Study completion date: Dec 30, 2023 to Sep 22, 2025
    • Interventions: BI1206 (Biological) to BI-1206 (Biological)
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 58 words
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date: Jun 30, 2020 to Mar 30, 2023
    • Study sites: 10 to 9
    • Study completion date: Jun 30, 2020 to Dec 30, 2023
    v6
  4. Site details revised at 6 of 10 sitesv5
  5. Study sites: 2 to 10v4
  6. Study sites: 1 to 2v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
Trial Details
NCT Number NCT03571568
Lead Sponsor BioInvent International AB
Conditions
(from sponsor)		 Indolent B-Cell Non-Hodgkin Lymphoma
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov