A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy - ACE-CL-208

Acerta Pharma B.V.0 sites60 target enrollmentFebruary 9, 2016

ConditionsHigh Risk Chronic Lymphocytic Leukemia MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsCalquence

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: High Risk Chronic Lymphocytic Leukemia
Sponsor: Acerta Pharma B.V.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 9, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Acerta Pharma B.V.

Eligibility Criteria

Inclusion Criteria

•1\. Men and women \= 18 years of age.
•2\. Prior diagnosis of CLL that meets published diagnostic criteria as follows:
•a. Monoclonal B\-cells (either kappa or lambda light chain restricted) that are clonally co\-expressing \= 1 B\-cell marker (CD19, CD20, or CD23\) and CD5\.
•b. Prolymphocytes may comprise \= 55% of blood lymphocytes.
•c. No evidence of cyclin D1 rearrangement or BCL\-1 over expression.
•d. Presence of \= 5 x 109 B lymphocytes/L (5000 µL) in the peripheral blood (at any point since diagnosis).
•3\. Must have received \= 1 prior therapy for CLL and not be appropriate for treatment or retreatment with purine analogue\-based therapy as defined by \= 1 of the following criteria:
•a. Failure to respond (stable disease \[SD] or disease progression on treatment) or progression\-free interval of \< 3 years from treatment with a purine analogue\-based therapy and anti\-CD20 antibody\-containing chemoimmunotherapy regimen after \= 2 cycles.
•b. Age \= 70 years
•c. Age \=65 years with the presence of 1 of the following comorbidities that might place the subject at an unacceptable risk for treatment\-related toxicity with purine analogue\-based therapy, provided they have received \=1 prior treatment including \=2 cycles of an alkylating\-agent based (or purine analogue\-based) anti\-CD20 antibody\-containing chemoimmunotherapy regimen:

Exclusion Criteria

•1\. Ongoing Grade 3 or 4 AE attributed to ibrutinib therapy. Note: Subjects may be eligible for enrollment once the ibrutinib\-related AE improves to Grade \= 2\.
•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 (e.g., 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 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 corrected QT interval (QTc) \> 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
•6\. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
•7\. Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
•8\. CNS involvement by CLL or related Richter’s transformation.
•9\. Known history of HIV, serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
•a) Subjects who are anti\-hepatitis B core antibody (anti\-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B PCR positive will be excluded.