Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL

Sponsor
University of Ulm
Study ID
NCT02758665
Phase
PHASE2
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic

Eligibility Criteria

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

Interventions

Study Details

A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus obinutuzumab in physically fit (CIRS ≤ 6 \& normal creatinine clearance) and unfit (CIRS \> 6 \& creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic leukemia (CLL) with TP53 deletion (17p-) and/or mutation

Key Dates

Start date
Sep 30, 2016
Status verified
Jan 2023
Primary completion
Jan 31, 2022
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: Obinutuzumab, Ibrutinib, Venetoclax
    Obinutuzumab i.v.: Cycle 1 (3000 mg), Cycle 2-6 (1000 mg) Ibrutinib (tablet): Cycle 1-15 (420 mg daily) Venetoclax (tablet): Cycle 1 (last 7 days 20 mg daily), Cycle 2 (ramp up 50 mg to 400 mg) Cycle 3-12 (400 mg daily)

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: at day 1 of cycle 15 (1 cycle = 28 days) after start of induction therapy ]

Related Studies