Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Sponsor
Inhye Ahn
Study ID
NCT04685915
Phase
PHASE2
Status
Withdrawn

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Capsule, taken by mouth once daily
  • Copanlisib — DRUG
    Intravenous Infusion
  • Acalabrutinib — DRUG
    Capsule, taken by mouth twice daily

Study Details

This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL). The names of the study drugs involved in this study are: * Copanlisib * Ibrutinib * Acalabrutinib

Key Dates

Start date
Feb 18, 2021
Status verified
Jan 2023
Primary completion
Mar 1, 2023
Completion
Mar 1, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Addition of copanlisib to either ibrutinib or acalabrutinib
    During the 28-day study treatment cycles, participants will: * Continue to take ibrutinib (daily) or acalabrutinib (twice a day) at a predetermined dose for as long as there are no serious side effects and disease progression * Receive intravenous infusion of copanlisib at a predetermined dose days 1, 8 and 15 for cycles 1-6.

Primary Outcome Measure

Complete response (CR) Rate [ Time Frame: 6 months ]

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