Clinical trial · Interventional
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 1 Proof-of-Concept Study Investigating AZD6738 Monotherapy and Acalabrutinib in Combination With AZD6738 (ATR Inhibitor) in Subjects With Relapsed or Refractory High-risk Chronic Lymphocytic Leukemia (CLL)
NCT03328273CI-TRIAL-00117902active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
| Ceralasertib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A Part 1 and 2
- description
- DISCONTINUED (ceralasertib monotherapy)
- interventionNames
- Drug: Ceralasertib
- type
- EXPERIMENTAL
- label
- Arm B Part 1 and 2
- description
- ceralasertib + acalabrutinib in combination
- interventionNames
- Drug: Ceralasertib
- Drug: Acalabrutinib
Primary outcomes (1)
- measure
- Number of participants experiencing dose-limiting toxicities
- timeFrame
- 28 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDJurczak W, Elmusharaf N, Fox CP, Townsend W, Paulovich AG, Whiteaker JR, Krantz F, Wun CC, Parr G, Sharma S, Munugalavadla V, Manwani R, Dean E, Munir T. Phase I/II results of ceralasertib as monotherapy or in combination with acalabrutinib in high-risk relapsed/refractory chronic lymphocytic leukemia. Ther Adv Hematol. 2023 May 30;14:20406207231173489. doi: 10.1177/20406207231173489. eCollection 2023. PMID 37273420