Status:
ACTIVE_NOT_RECRUITING
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Acerta Pharma BV
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief Summary
This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.
Detailed Description
This study is to determine the safety of ceralasertib when given as monotherapy (discontinued) and in combination with acalabrutinib in subjects with R/R CLL and in subjects who have few therapeutic o...
Eligibility Criteria
Inclusion
- Diagnosis of relapsed or refractory CLL that meets published diagnostic criteria (International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] Hallek 2008) and supported/documented by medical records
- Subjects must be Relapse/Refractory high risk CLL and have exhausted other therapeutic options according to local/regional standard of care
- Must have received ≥1 prior therapy for treatment of their disease.
Exclusion
- A diagnosis of ataxia telangiectasia
- Any prior exposure to an ATR inhibitor or known hypersensitivity to an excipient of the product.
- Known history of infection with human immunodeficiency virus (HIV).
- 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 (acalabrutinib) and/or Ceralasertib
- 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.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Requirement of treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- Breast feeding or pregnant
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03328273
Start Date
January 31 2018
End Date
August 26 2026
Last Update
September 15 2025
Active Locations (11)
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1
Research Site
Krakow, Poland, 30-510
2
Research Site
Lodz, Poland, 93-510
3
Research Site
Birmingham, United Kingdom, B9 5SS
4
Research Site
Bournemouth, United Kingdom, BH7 7DW