Trial intelligence / Profile preview

Venetoclax and Obinutuzumab in untreated CLL (CRISTALLO)

NCT04285567Phase 3

Key facts

Status: Completed
Start: May 2020
Primary completion: Mar 2024
Countries: 5
Sponsor: Roche
Modality: Antibody Conjugates, Monoclonal Antibodies, Engineered Antibody Formats

Drugs: venetoclaxobinutuzumab
Conditions: chronic lymphocytic leukemia (CLL)

Overview

Phase 3, randomised, open-label trial of venetoclax and obinutuzumab in chronic lymphocytic leukemia (CLL), sponsored by Roche. Primary endpoint: Minimal Residual Disease Response Rate Measured in Peripheral Blood Using Next Generation Sequencing at 15 months. Started May 2020; status: completed.

Design

Study design: RandomizedOpen-label

Who it enrols

Fit patients (CIRS ≤ 6, CrCl ≥ 70 mL/min) with previously untreated CLL requiring treatment, without del(17p) or TP53 mutations.

Endpoints

Primary

Minimal Residual Disease Response Rate Measured in Peripheral Blood Using Next Generation Sequencing15 months

Secondary

Progression-free Survival56.4 months
Minimal Residual Disease Response Rate in Peripheral Blood15 months
Minimal Residual Disease Response Rate in Bone Marrow15 months
Objective Response Rate15 months
Complete Response Rate15 months
Duration of Objective Response56.4 months
Overall Survival56.4 months
Tumor Lysis Syndrome Risk Reduction Rate3.1 weeks

Results

Primary endpoints met

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