Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Pharmacyclics

Status and phase: Completed; Phase 3

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Ibrutinib; Drug: Next-line ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01724346

2012-003968-44 (EudraCT Number)

PCYC-1116-CA

Details and patient eligibility

About

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Enrollment: 269 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Randomized in the parent study, PCYC-1115-CA
2. Informed consent for Study PCYC-1116-CA
3. Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study

Exclusion criteria

1. Disease progression involving the central nervous system (CNS) or transformation to another histology
2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
4. Requirement for treatment with a strong CYP3A inhibitor
5. Uncontrolled systemic infection or requirement for IV antibiotics
6. Noncompliance on the parent study(PCYC-1115-CA)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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269 participants in 2 patient groups

Chlorambucil

Experimental group

Description:

Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD).

Treatment:

Drug: Ibrutinib

Ibrutinib

Experimental group

Description:

Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.

Treatment:

Drug: Next-line ibrutinib