Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
45

Summary

Conditions
  • Chronic Lymphocytic Leukemia
  • Prolymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

A Phase 1b Study of ACP-196 in Combination with Obinutuzumab for Patients with Relapsed/Refractory or Untreated CLL/SLL/PLL Study started with two cohorts, on Acalabrutinib and Obinutuzumab, cohort 1 for relapsed or refractory patients and cohort two for treatment naïve subjects. Then for longer sur...

A Phase 1b Study of ACP-196 in Combination with Obinutuzumab for Patients with Relapsed/Refractory or Untreated CLL/SLL/PLL Study started with two cohorts, on Acalabrutinib and Obinutuzumab, cohort 1 for relapsed or refractory patients and cohort two for treatment naïve subjects. Then for longer survival data and combination therapy, two new cohorts added to the study, cohort 3 with relapsed or refractory subjects on Acalabrutinib, Rituximab and Venetoclax, and cohort 4 with treatment naïve subjects on Acalabrutinib, Obinutuzumab and Venetoclax. Primary endpoints: For Cohorts 1 and 2, the ORR (PR or better) at the 12-month response assessment will be calculated and 95% exact binomial CIs will be provided. For Cohorts 1 to 4, toxicities will be tabulated by type and grade using NCI-CTCAE version 4.03 criteria or higher and displayed in summary form. Currently study is in maintenance phase and we don't expect a major change in the near future.

Tracking Information

NCT #
NCT02296918
Collaborators
Not Provided
Investigators
Study Director: AstraZeneca Study Information Center 1-877-240-9479; information.center@astrazeneca.com