Study identifier:ACE-CL-001
ClinicalTrials.gov identifier:NCT02029443
EudraCT identifier:2014-000440-15
CTIS identifier:N/A
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
Chronic Lymphocytic Leukemia
Phase 1/2
No
Acalabrutinib
All
306
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AcertaPharma
AcertaPharma
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Relapsed/Refractory Cohort Phase 1 (dose-escalation) and Phase 2 (dose-expansion) will be conducted for participants with relapsed/refractory CLL or SLL. In Phase 1, participants will receive oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants will receive oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later will be switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. Participants from Phase 1 will be continued to receive Dose 1 BID until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. | Drug: Acalabrutinib Participants will receive acalabrutinib as stated in the arms' description. Other Name: ACP-196 |
Experimental: Treatment-naive Cohort Treatment-naïve participants with confirmed CLL or SLL, will receive oral acalabrutinib Dose 5 QD (Cohort 7, later will be switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. | Drug: Acalabrutinib Participants will receive acalabrutinib as stated in the arms' description. Other Name: ACP-196 |
Experimental: Ibrutinib-intolerant Cohort Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. | Drug: Acalabrutinib Participants will receive acalabrutinib as stated in the arms' description. Other Name: ACP-196 |
Experimental: Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort Participants with diffuse large B-cell lymphoma (DLBCL) Richter’s transformation (RS) or prolymphocytic leukemia (PLL) transformation, will receive oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. | Drug: Acalabrutinib Participants will receive acalabrutinib as stated in the arms' description. Other Name: ACP-196 |
Experimental: Ibrutinib Relapsed/Refractory Cohort Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant’s best interest. | Drug: Acalabrutinib Participants will receive acalabrutinib as stated in the arms' description. Other Name: ACP-196 |