Conditions: Chronic Lymphocytic Leukemia With 17p Deletion Small Lymphocytic Lymphoma With 17p Deletion
Keywords: CLL SLL
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 145
Healthy volunteers: no

Brief summary:
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

Detailed description:
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.

Arms:
arm 1: All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.

Interventions: intervention 1: Ibrutinib
Intervention descriptions: intervention 1: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Protocol document: