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Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT04073147•Klinikum Stuttgart

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at inclusion ≥ 18 to 80 years, in case of ECOG 0 to 1 age up to 85 years
•2. Eastern Cooperative Group performance status (ECOG) ≤ 3
•3. Evaluable lymphoma manifestation in the CNS, either contrast-enhanced lesion in the brain parenchyma or measurable meningeal lesions.
•4. Biopsy proven CD20 positive PCNSL at initial diagnosis or previous relapse/progression (re-biopsy at study inclusion is not mandatory for inclusion, but strongly recommended if time in remission is longer than 24 months).
•5. At least one prior HD-MTX containing chemotherapy application (MTX dosed at ≥ 1 g/m2 body surface area) before progression or relapse.
•6. Confirmed relapsed or refractory PCNSL according to the IPCG response criteria with the following definition: Evidence of disease recurrence following PR/CR or uCR or no radiological response (SD or PD) as per the IPCG criteria to prior chemotherapy regimen(s), at least one of them containing high-dose methotrexate.
•7. Absolute neutrophil count (ANC) of at least 1'500/μl
•8. Platelet count of at least 50'000/μl
•9. Adequate liver (alanine aminotransferase \[ALAT\] and AST ≤ 3.0 x upper limit of normal \[ULN\] and total bilirubin ≤ 1.5 x ULN) and kidney function (estimated ≥ 30ml/min creatinine clearance according to Cockgroft-Gault formula)
•10. Written informed consent
+1 more criteria

Exclusion Criteria

•1. Known allergy to venetoclax or other components of the formulation
•2. Known allergy to obinutuzumab or other components of the formulation
•3. Primary ocular lymphomas without brain parenchymal involvement
•4. Lymphoma relapse outside the CNS; extra CNS relapse needs to be ruled out by body CT scans (neck till pelvis) or PET-CT scans.
•5. Contraindications for lumbar puncture at the discretion of the clinical investigator
•6. Prior exposure to obinutuzumab or venetoclax
•7. Other additional anti-lymphoma treatment, e.g. chemotherapy or radiotherapy
•8. Active hepatitis B or C
•9. HIV seropositivity
•10. Chronic use of immunosuppressive drugs, e.g. steroids for systemic autoimmune disease
+9 more criteria

Locations (1)

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Key Dates

Start Date

May 12, 2020

Primary Completion Date

November 25, 2021

Completion Date

November 25, 2021

Last Updated

January 19, 2022

Enrollment

ACTUAL participants

Conditions

Primary CNS Lymphoma

Interventions

Venetoclax

DRUG

Obinutuzumab

DRUG

Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab

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Primary CNS Lymphoma (PCNSL)

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RECRUITINGNA

Diagnosis; Objective RespOnse; THErApy

NCT05036564

Primary CNS Lymphoma

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ACTIVE_NOT_RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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