Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma

Phase 1

Terminated

• Conditions: Primary CNS Lymphoma
• Interventions: Drug: Venetoclax; Drug: Obinutuzumab

• Registration Number: NCT04073147
• Lead Sponsor: Klinikum Stuttgart

Brief Summary

This is a phase IB study investigating the pharmacokinetics of the combination venetoclax and obinutuzumab in the cerebrospinal fluid of patient with relapsed primary CNS lymphoma.

Detailed Description

This is a phase IB study investigating the pharmacokinetics of the combination venetoclax and obinutuzumab in the cerebrospinal fluid of patient with relapsed primary CNS lymphoma. Three dosing groups of venetoclax (600mg, 800mg, and 1000mg) are planned; dosing of obinutuzumab will be 1000mg for each dosing group. 15 patients are planned being included from two centers in Germany.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Study Start: 2020-05-12
• Primary Completion: 2021-11-25
• Study Completion: 2021-11-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dosing group 3	Venetoclax	Venetoclax 1000mg + Obinutuzumab 1000mg
Dosing group 1	Venetoclax	Venetoclax 600mg + Obinutuzumab 1000mg
Dosing group 1	Obinutuzumab	Venetoclax 600mg + Obinutuzumab 1000mg
Dosing group 2	Venetoclax	Venetoclax 800mg + Obinutuzumab 1000mg
Dosing group 2	Obinutuzumab	Venetoclax 800mg + Obinutuzumab 1000mg
Dosing group 3	Obinutuzumab	Venetoclax 1000mg + Obinutuzumab 1000mg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of venetoclax and obinutuzumab	day 3, 15, and 28	Serum concentration and CSF concentration (μg/ml)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival 2 (PFS2)	Up to 12 months	Time from the start of maintenance venetoclax treatment at week 12 until date of progression, relapse or death, whichever occurs first.
Dose limiting toxicities	Within the first 6 weeks	Defined by CTCAE (version 5.0)
Best lymphoma response achieved during induction	During induction (3 months)	According to IPCG criteria
Progression-free survival 1 (PFS1)	Up to 15 months	Time from the date of first dose until date of progression, relapse or death, whichever occurs first
Overall survival	Up to 15 months	Time from the date of first dose until date of death
Mutational landscape of lymphoma	At baseline	NGS test based on FoundationOne Heme® platform

Trial Locations

Locations (1)

Klinikum Stuttgart; 🇩🇪 Stuttgart, Baden-Württemberg, Germany