Beschreibung

Rekrutierung gestartet

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

Studienstatus

Abgeschlossen

Indikation

ZNS Lymphom

Anzahl Patienten

15

Alter der Patienten

Studienphase

Phase I

Spezifische Infos zum Antrag

Age at inclusion ?18 to 80 years, in case of ECOG 0 to 1 age up to 85years
Eastern Cooperative Group performance status (ECOG) ? 3
Evaluable lymphoma manifestation in the CNS, either contrast-enhanced lesion in the brain parenchyma or measurable meningeal lesions.
Biopsy proven CD20 positive PCNSL at initial diagnosis or previous relapse (re-biopsy at study inclusion is not mandatory for inclusion, but strongly recommended if time in remission is longer than 24 months).
At least one prior HD-MTX containing chemotherapy application (MTX dosed at ? 1 g/m2 body surface area) before progression or relapse.
Confirmed lymphoma relapse according to the IPCG response criteria.
Absolute neutrophil count (ANC) of at least 1'500/?l
Platelet count of at least 50'000/?l

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)
Written informed consent
Recovery from toxicity from previous anti-lymphoma treatment to ?grade 2

Known allergy to venetoclax or other components of the formulation
Known allergy to obinutuzumab or other components of the formulation
Primary ocular lymphomas without brain parenchymal involvement
Lymphoma relapse outside the CNS; extra CNS relapse needs to be ruled out by body CT scans (neck till pelvis) or PET-CT scans.
Contraindications for lumbar puncture at the discretion of the clinical investigator
Prior exposure to obinutuzumab or venetoclax
Other additional anti-lymphoma treatment, e.g. chemotherapy or radiotherapy
Active hepatitis B or C
HIV seropositivity
Chronicuseofimmunosuppressivedrugs,e.g.steroidsforsystemic autoimmune disease
Active infections requiring treatment
Other active malignancies (except non-melanoma skin cancer). Prior malignancies without evidence of disease for at least 5 years are allowed
Patient is pregnant or breastfeeding, or expecting to conceive or father children within one year of finishing venetoclax and 18 months for obinutuzumab.
Prior allogeneic haematopoietic stem cell or solid organ transplantation
Participation in any other interventional clinical trial within the last 30 days before the start of this trial; simultaneous participation in registry and diagnostic studies is allowed
Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
Known or persistent abuse of medication, drugs or alcohol
Personwhoisinarelationshipofdependence/employmentwiththesponsor or the investigator
Administration of moderate or strong CYP3A inhibitors or inducers within 1 week of initiation of venetoclax dosing.

Nein