A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

Conditions

• Chronic Lymphocytic Leukemia With 17p Deletion
• Small Lymphocytic Lymphoma With 17p Deletion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Study Details

An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion

Key Dates

Start date

Jan 31, 2013

Status verified

Jan 2017

Primary completion

Jun 30, 2014

Completion

Apr 30, 2016

Study Design

Enrollment

145 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ibrutinib
  All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.

Primary Outcome Measure

Overall Response Rate [ Time Frame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months ]

Locations (18)