Clinical Study With Ibrutinib and Venetoclax for Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

Sponsor
Paolo Ghia
Study ID
NCT04754035
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    venetoclax 20 mg, 50 mg, 100 mg
  • Imbruvica Oral Product — DRUG
    Imbruvica 140 mg

Study Details

This is a Phase 2a, multicenter, open-label uncontrolled study aimed at determining therapeutic benefits of the addition of ibrutinib to venetoclax in patients with relapsed/refractory CLL based on a MRD-guided approach.

Key Dates

Start date
Nov 8, 2017
Status verified
Oct 2023
Primary completion
Jul 31, 2018
Completion
Sep 1, 2025

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: venetoclax + ibrutinib

Primary Outcome Measure

Minimal residual disease [ Time Frame: 4 years ]

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