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Bending the Curve Trial by Trial
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Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia (phase 1b-2)

Phase 1/2N = 85NCT01105247

Population
Relapsed or refractory CLL or SLL; the majority were considered to have high-risk disease
Design
Multicentre phase 1b-2 single-arm study of oral once-daily ibrutinib in relapsed or refractory CLL or SLL; 51 patients received 420 mg and 34 received 840 mg. Safety, efficacy, pharmacokinetics and pharmacodynamics were assessed. The ClinicalTrials.gov record lists 133 enrolled (the paper reports 85 patients).
Arms
  • Ibrutinib (all patients) (experimental, n = 85): Ibrutinib orally once daily, 420 mg (51 patients) or 840 mg (34 patients)
People
Byrd JC, senior author O'Brien S
Show the numbers
Results reported for Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia (phase 1b-2)
EndpointAnalysisIbrutinib (all patients)ControlEffect
ORRPatients who received ibrutinib (n=85); the abstract does not name a primary endpoint or state an analysis populationprimaryByrd 201371%—Reported as 71% in the 420 mg group and 71% in the 840 mg group; an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis.
PFSPatients who received ibrutinib (n=85); estimated rate as stated in the abstractprimaryByrd 201375% at 26 mo—Estimated progression-free survival rate at 26 months.
OSPatients who received ibrutinib (n=85); estimated rate as stated in the abstractprimaryByrd 201383% at 26 mo—Rate of overall survival at 26 months.
Results reported for Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia (phase 1b-2)
EndpointAnalysisIbrutinib (all patients)ControlEffect
ORRPatients who received ibrutinib (n=85); the abstract does not name a primary endpoint or state an analysis populationprimaryByrd 201371%—Reported as 71% in the 420 mg group and 71% in the 840 mg group; an additional 20% and 15% of patients in the respective groups had a partial response with lymphocytosis.
PFSPatients who received ibrutinib (n=85); estimated rate as stated in the abstractprimaryByrd 201375% at 26 mo—Estimated progression-free survival rate at 26 months.
OSPatients who received ibrutinib (n=85); estimated rate as stated in the abstractprimaryByrd 201383% at 26 mo—Rate of overall survival at 26 months.
Primary publication: Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42. PubMedDOI

Appears in

Sources

  1. Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42.

    PubMedDOI