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

Pharmacyclics

Status and phase: Completed; Phase 2

Conditions: Small Lymphocytic Lymphoma With 17p Deletion; Chronic Lymphocytic Leukemia With 17p Deletion

Treatments: Drug: Ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01744691

2012-004476-19 (EudraCT Number)

PCYC-1117-CA

Details and patient eligibility

About

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

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Documentation of del (17p13.1)
• Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
• Measurable nodal disease by computed tomography (CT)

Key Exclusion Criteria:

• History or current evidence of Richter's transformation or prolymphocytic leukemia
• Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
• Prior exposure to ibrutinib

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

ibrutinib

Experimental group

Description:

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

Treatment:

Drug: Ibrutinib