trialsTrialActive

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

A phase 2 trial of Acalabrutinib in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy is a phase 2 interventional study registered as NCT02717611 by Acerta Pharma BV, with 60 participants enrolled, started 2016-03-08 and due to reach its primary completion in 2020-10-16. Interventions recorded: ACP-196 (acalabrutinib). Results have been posted on the registry.

Setting

A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Phase

Phase 2

Sponsor

Acerta Pharma BV

Registry

Started

2016-03-08

Reported

2022

Enrolled

60 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

60 enrolled

The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)primaryresponse endpoint

70 out of 100 people had their tumour shrink with Acalabrutinib.

There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
These results apply to the people the trial enrolled: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy. People in a different situation may not see the same effect.
Only 60 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

60 enrolled.

The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)primary

Acalabrutinib70 of 100

n = 60

Download

95% CI 56.8 to 81.2; Figures from the ClinicalTrials.gov results section (first posted 2022-02-09), not from a publication

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)primary	Acalabrutinib	60	70%	-	-	link

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cancers

Chronic lymphocytic leukaemia Relapsed or refractory chronic lymphocytic leukaemia

technologies

Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule covalent BTK inhibitor (second generation)

Acalabrutinib · Calquence

companies