An Open-label, Phase 1b Study of ACP 196 Alone or in Combination With Rituximab in Subjects With Follicular Lymphoma
Conditions
Follicular Lymphoma (FL)
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Bruton tyrosine kinase inhibitor, Btk, Follicular Lymphoma, FL
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ACP-196 Type: Drug
Name: rituximab (IV) Type: Drug
Overall Status
Recruiting
Summary
To characterize the safety profile of ACP 196 alone or in combination with rituximab in subjects with relapsed or refractory Follicular Lymphoma (FL)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Men and women ≥ 18 years of age.

- A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

- •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk

- Significant cardiovascular disease such as uncontrolled or symptomatic 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

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

- Breast feeding or pregnant
Locations
Atlanta, Georgia, United States
Status: Not yet recruiting
New York, New York, United States
Status: Recruiting
Columbus
Columbus, Ohio, United States
Status: Recruiting
Houston, Texas, United States
Status: Recruiting
Start Date
July 2014
Sponsors
Acerta Pharma BV
Source
Acerta Pharma BV
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page