Trials / Terminated
TerminatedNCT04073147
Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma
Chemotherapy Free Treatment With Venetoclax and Obinutuzumab for Relapsed / Refractory Primary CNS Lymphoma Patients (VENOBI-CNS Study) - A Phase IB Study to Assess the Pharmacokinetics in the Cerebrospinal Fluid
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Klinikum Stuttgart · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | Venetoclax per os |
| DRUG | Obinutuzumab | ObintuzumabIV |
Timeline
- Start date
- 2020-05-12
- Primary completion
- 2021-11-25
- Completion
- 2021-11-25
- First posted
- 2019-08-29
- Last updated
- 2022-01-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04073147. Inclusion in this directory is not an endorsement.