Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Protocol: OSU-15275

Full Title

A Phase II Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Purpose

A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects

with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Are you eligible?

Inclusion Criteria:

Inclusion Criteria:

1. Men and women ≥ 18 years of age.

2. Prior diagnosis of CLL

3. Must have received ≥ 1 prior therapy for CLL

4. Intolerant of ibrutinib

5. Willing and able to participate in all required evaluations and procedures in this

study protocol including swallowing capsules without difficulty.

6. ECOG performance status of ≤ 2.

Exclusion Criteria:

1. Ongoing AE attributed to ibrutinib therapy

2. Treatment with systemic anticancer therapy for CLL is prohibited between

discontinuation of ibrutinib and enrollment on this trial.

3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)

4. Prior malignancy (other than CLL), except for adequately treated basal cell or

squamous cell skin cancer, in situ cancer, or other cancer from which the subject has

been disease free for ≥ 2 years.

5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated

arrhythmias, congestive heart failure, or myocardial infarction within 6 months of

screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart

Association Functional Classification, or QTc > 480 msec at screening. Exception:

Subjects with controlled, asymptomatic atrial fibrillation during screening are

allowed to enroll on study.

Exclusion Criteria:

Inclusion Criteria:

1. Men and women ≥ 18 years of age.

2. Prior diagnosis of CLL

3. Must have received ≥ 1 prior therapy for CLL

4. Intolerant of ibrutinib

5. Willing and able to participate in all required evaluations and procedures in this

study protocol including swallowing capsules without difficulty.

6. ECOG performance status of ≤ 2.

Exclusion Criteria:

1. Ongoing AE attributed to ibrutinib therapy

2. Treatment with systemic anticancer therapy for CLL is prohibited between

discontinuation of ibrutinib and enrollment on this trial.

3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)

4. Prior malignancy (other than CLL), except for adequately treated basal cell or

squamous cell skin cancer, in situ cancer, or other cancer from which the subject has

been disease free for ≥ 2 years.

5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated

arrhythmias, congestive heart failure, or myocardial infarction within 6 months of

screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart

Association Functional Classification, or QTc > 480 msec at screening. Exception:

Subjects with controlled, asymptomatic atrial fibrillation during screening are

allowed to enroll on study.

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