Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Non Hodgkin Lymphoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Intervention Model: Sequential AssignmentMasking: None (Open Label)Masking Description: A multicentre open-label non-randomised phase Ib/II two stage trial. Stage 1 - dose escalation will proceed until a maximum tolerated dose (MTD) is defined or the maximal administered dose (MAD) is determined in order to define the recommended Phase II dose (RP2D). 6 - 24 patients. Stage 2 - expansion to gain additional information on safety and efficacy at the RP2D from a total of 15 patients recruited. Patients will receive conventionally dosed R-CHOP chemotherapy for 6 cycles with acalabrutinib introduced on cycle 2 onwards, at a dosage according to cohort number. This will allow for both clarity in the toxicity profile of the combination and also assess the impact of acalabrutinib on ADCC. patients who do not complete six cycles of treatment for reasons other than toxicity will be replaced.Primary Purpose: Treatment

Participation Requirements

Age
Between 16 years and 125 years
Gender
Both males and females

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.

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.

Tracking Information

NCT #
NCT03571308
Collaborators
Not Provided
Investigators
Principal Investigator: Andy Davies Southampton University Hospital NHS Foundation Trust
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