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Trials / Completed

CompletedNCT03571308

A Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL)

A Phase Ib/II Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL)

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
39 (actual)
Sponsor
University Hospital Southampton NHS Foundation Trust · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL) requiring full course chemoimmunotherapy.

Detailed description

Open-label non-randomised phase Ib/II study conducted in two stages. Stage 1 will be dose escalation in a modified classical 6+6 design. Stage 2 will be an expansion cohort to gain additional information on safety and efficacy at the recommended phase II dose of acalabrutinib.

Conditions

Interventions

TypeNameDescription
DRUGR-CHOP + acalabrutinibPatient will be given R-CHOP and acalabrutinib

Timeline

Start date
2017-06-02
Primary completion
2020-01-02
Completion
2023-08-31
First posted
2018-06-27
Last updated
2023-09-28

Locations

7 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03571308. Inclusion in this directory is not an endorsement.

A Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL) (NCT03571308) · Clinical Trials Directory