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An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509350-63-00
Acronym
ACE-LY-003
Enrollment
2
Registered
2024-10-28
Start date
2020-09-16
Completion date
Unknown
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory marginal zone lymphoma

Brief summary

Efficacy: Investigator-assessed ORR according to the Lugano classification for NHL.

Detailed description

Monitoring and recording AEs and SAEs; hematology, serum chemistry, serum Ig, and T/B/NK-cell count results; vital signs measurements; ECOG; and concomitant medications., Investigator-assessed DOR, PFS, and OS according to the Lugano classification for NHL

Interventions

DRUGCalquence 100 mg film-coated tablets
DRUGCalquence 100 mg hard capsules

Sponsors

Acerta Pharma B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Efficacy: Investigator-assessed ORR according to the Lugano classification for NHL.—

Secondary

MeasureTime frame
Monitoring and recording AEs and SAEs; hematology, serum chemistry, serum Ig, and T/B/NK-cell count results; vital signs measurements; ECOG; and concomitant medications., Investigator-assessed DOR, PFS, and OS according to the Lugano classification for NHL—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026