Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT03455517
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax and rituximab association
  • Rituximab — DRUG
    Venetoclax and rituximab association

Study Details

Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses.

Key Dates

Start date
Oct 31, 2018
Status verified
Nov 2023
Primary completion
Sep 5, 2021
Completion
May 11, 2023

Study Design

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

Arms

  • Experimental: Veritas
    * Step 1. All patients: venetoclax 5-weeks dose-titration phase with weekly increases in the dose of venetoclax. * Step 2. All patients will receive 6 courses of the VR combination. * Step 3. After 6 courses of VR combination: 3a. Patients with no response will be off treatment; 3b. Patients with clinical response (CR or PR) after 6 courses of VR combination will receive venetoclax as a single agent for 6 months. Then, patients will be observed clinically until disease progression or until month 36.

Primary Outcome Measure

Number of patients achieving complete response (CR) [ Time Frame: At 15 months from treatment start, which is the end of treatment ]

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