Erudio Healtherudio.com
Clinical trial · no report yet · Phase 1/Phase 2
ACE-CL-001
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
- NCT02029443 ↗
- Active, not recruiting
- Acerta Pharma BV
- Focused
We haven't built an HCP commentary report on ACE-CL-001 (acalabrutinib in chronic lymphocytic leukemia, Richter's syndrome or prolymphocytic leukemia) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on ACE-CL-001 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 4 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Richter's Syndrome; Prolymphocytic Leukemia
- Interventions
- Acalabrutinib
- Arms
- Relapsed/Refractory Cohort · Experimental
- Treatment-naive Cohort · Experimental
- Ibrutinib-intolerant Cohort · Experimental
- Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort · Experimental
- Ibrutinib Relapsed/Refractory Cohort · Experimental
- Enrollment
- 306
- Primary outcomes
- Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
- Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
- Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
- Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
- Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib
- Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
- Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
- Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib
- Terminal Elimination Half-life (t1/2) of Acalabrutinib
- Terminal Elimination Rate Constant (λz) of Acalabrutinib
- Apparent Oral Clearance (CL/F) of Acalabrutinib
- Apparent Volume of Distribution (Vz/F) of Acalabrutinib
- Sponsor
- Acerta Pharma BV
- Start
- Jan 30, 2014
- Primary completion
- Jul 15, 2021
- Results posted
- Yes
- Registry record
- NCT02029443 · updated May 5, 2026
Publications
linked from the registry- Furman RR, Wierda WG, Patten PEM, Chaves JM, Brown JR, Munir T, Martin P, Awan FT, Stephens DM, Ghia P, Barrientos JC, Patel K, Woyach JA, de Borja M, Wang MH, Jain N, O'Brien SM, Byrd JC. Final phase 2 study results of acalabrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2026 Jun 9;10(11):3931-3941. doi: 10.1182/bloodadvances.2025018310. PubMed 41915892
- Nuttall B, Karl DL, Burke K, Callahan M, Mendler K, Cingolani P, Criscione S, Naumenko S, Bibikova E, Munugalavadla V, Byrd JC, Furman RR, Brown JR, Mortlock A, Dougherty BA, Carl Barrett J, Scaltriti M, Hadfield J. Comprehensive comparison of enzymatic and bisulfite DNA methylation analysis in clinically relevant samples. Clin Epigenetics. 2025 Oct 3;17(1):156. doi: 10.1186/s13148-025-01959-0. PubMed 41044668
- Bibikova E, Parsa S, Floren M, Law B, Clevenger T, Cheung J, De Jesus G, Burke K, Gulrajani M, Yamaguchi K, Do P, Dougherty B, Whitston D, Brock G, Munugalavadla V, Frigault MM, Hartmann TN, Byrd JC, Furman RR, Brown JR, Covey T, Mortlock A. Molecular Profiling Identifies CD49d and CD79b as Predictive Markers for Acquired Acalabrutinib Resistance in Patients With Chronic Lymphocytic Leukemia. Hematol Oncol. 2025 Jan;43(1):e70008. doi: 10.1002/hon.70008. PubMed 39716442
- Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024. PubMed 39563886
- Eyre TA, Schuh A, Wierda WG, Brown JR, Ghia P, Pagel JM, Furman RR, Cheung J, Hamdy A, Izumi R, Patel P, Wang MH, Xu Y, Byrd JC, Hillmen P. Acalabrutinib monotherapy for treatment of chronic lymphocytic leukaemia (ACE-CL-001): analysis of the Richter transformation cohort of an open-label, single-arm, phase 1-2 study. Lancet Haematol. 2021 Dec;8(12):e912-e921. doi: 10.1016/S2352-3026(21)00305-7. Epub 2021 Nov 1. PubMed 34735860
- Byrd JC, Wierda WG, Schuh A, Devereux S, Chaves JM, Brown JR, Hillmen P, Martin P, Awan FT, Stephens DM, Ghia P, Barrientos J, Pagel JM, Woyach JA, Burke K, Covey T, Gulrajani M, Hamdy A, Izumi R, Frigault MM, Patel P, Rothbaum W, Wang MH, O'Brien S, Furman RR. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020 Apr 9;135(15):1204-1213. doi: 10.1182/blood.2018884940. PubMed 31876911
- Awan FT, Schuh A, Brown JR, Furman RR, Pagel JM, Hillmen P, Stephens DM, Woyach J, Bibikova E, Charuworn P, Frigault MM, Hamdy A, Izumi R, Linghu B, Patel P, Wang MH, Byrd JC. Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib. Blood Adv. 2019 May 14;3(9):1553-1562. doi: 10.1182/bloodadvances.2018030007. PubMed 31088809
- Long M, Beckwith K, Do P, Mundy BL, Gordon A, Lehman AM, Maddocks KJ, Cheney C, Jones JA, Flynn JM, Andritsos LA, Awan F, Fraietta JA, June CH, Maus MV, Woyach JA, Caligiuri MA, Johnson AJ, Muthusamy N, Byrd JC. Ibrutinib treatment improves T cell number and function in CLL patients. J Clin Invest. 2017 Aug 1;127(8):3052-3064. doi: 10.1172/JCI89756. Epub 2017 Jul 17. PubMed 28714866
- Byrd JC, Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, Chaves J, Wierda WG, Awan FT, Brown JR, Hillmen P, Stephens DM, Ghia P, Barrientos JC, Pagel JM, Woyach J, Johnson D, Huang J, Wang X, Kaptein A, Lannutti BJ, Covey T, Fardis M, McGreivy J, Hamdy A, Rothbaum W, Izumi R, Diacovo TG, Johnson AJ, Furman RR. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jan 28;374(4):323-32. doi: 10.1056/NEJMoa1509981. Epub 2015 Dec 7. PubMed 26641137