ObinutuzuMab AtezOlizumab and VenetocLax in RichTer transfOrmation

Conditions

• CLL Transformation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Obinutuzumab 25 MG/ML [Gazyva] — DRUG
  Obinutuzumab will be administered from C1 to C8
• Atezolizumab 60 MG/ML [Tecentriq] — DRUG
  Atezolizumab will be administered iv from C1 to C18
• Venetoclax Oral Tablet — DRUG
  Venetoclax will be administered from day 15 cycle 1) until day 21 of cycle 35

Study Details

This study is a multicenter, open-label, uncontrolled, phase II trial aimed to establish the safety and tolerability of venetoclax, atezolizumab and obinutuzumab combination in Richter Transformation of CLL.

Key Dates

Start date

Oct 4, 2019

Status verified

May 2024

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Combination of Obinutuzumab, Atezolizumab and Venetoclax
  Obinutuzumab will be administered iv from cycle 1 to cycle 8 : * cycle1: 100 mg iv (day 1) and 900 mg iv (day 2) 1000mg iv (day 8 and day 15) * Cycle 2-8: 1000 mg iv on day 1 Atezolizumab will be administered iv at 1.200 mg fixed dose from C1 to C18: * Cycles 1: day 2 * Cycle 2-18: day 1 Venetoclax will start from day 15 of cycle 1 on a weekly ramp-up basis: week 1: 20 mg (from day 15 cycle 1) week 2: 50 mg (from day 1 to day 7 cycle 2) week 3: 100 mg (from day 8 to day 14 cycle 2) week 4 200 mg (from day 15 to day 21 cycle 2) week 5: 400 mg (from day 1 cycle 3) venetoclax will be thereafter continued until day 21 of cycle 35

Primary Outcome Measure

Efficacy of the combination venetoclax, obinutuzumab and atezolizumab in terms of Overall Response Rate (ORR) [ Time Frame: First 6 cycles of therapy (each cycle is 21 days) ]