Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma
- Sponsor
- Klinikum Stuttgart
- Study ID
- NCT04073147
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Primary CNS Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax — DRUGVenetoclax per os
- Obinutuzumab — DRUGObintuzumabIV
Study Details
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.
Key Dates
- Start date
- May 12, 2020
- Status verified
- Jan 2022
- Primary completion
- Nov 25, 2021
- Completion
- Nov 25, 2021
Study Design
- Enrollment
- 4 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dosing group 1Venetoclax 600mg + Obinutuzumab 1000mg
- Experimental: Dosing group 2Venetoclax 800mg + Obinutuzumab 1000mg
- Experimental: Dosing group 3Venetoclax 1000mg + Obinutuzumab 1000mg
Primary Outcome Measure
Pharmacokinetics of venetoclax and obinutuzumab [ Time Frame: day 3, 15, and 28 ]