GIVE trial (Gazyvaro In combination with VEnetoclax in Elderly CLL)

Trial details

Who runs it

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Trial code

EU 2024-511048-22-00

Record updated

2024. május 28.

Original description

To separately study the efficacy, defined as MRD negative bone marrow and no progression according to the IWCLL criteria, of the two arms of the study of either venetoclax maintenance or MRD-guided venetoclax maintenance after sequential regimens of obinutuzumab (pre-induction) followed by 6 cycles obinutuzumab with venetoclax and 6 cycles of venetoclax (induction) in first-line patients with CLL and unfit for FCR like regimens.Read full original descriptionShow less

HOVON 139 CLL: A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial).

To separately study the efficacy, defined as MRD negative bone marrow and no progression according to the IWCLL criteria, of the two arms of the study of either venetoclax maintenance or MRD-guided venetoclax maintenance after sequential regimens of obinutuzumab (pre-induction) followed by 6 cycles obinutuzumab with venetoclax and 6 cycles of venetoclax (induction) in first-line patients with CLL and unfit for FCR like regimens.

Inclusion: Diagnosis of symptomatic CLL (according to IWCLL guidelines); Negative serum or urine pregnancy test within 28 days prior to registration (all females of childbearing potential); Written informed consent; Patient is capable of giving informed consent; Patients without prior treatment for CLL (Corticoid treatment administered due to necessary immediate intervention is allowed; within the last 10 days before start of study treatment only dose equivalents of max 20 mg prednisolone are permitted); Patients older than 18 years, not fit tor FCR-like regimens; Able to adhere to the study visit schedule and other protocol requirements; WHO performance status of <= 2; absolute neutrophil count >= 1.0 x 109/l and platelet count >= 50 x 109/l unless due to bone marrow infiltration; creatinine clearance>= 45 ml/min; total bilirubin <= 1,5 x ULN unless considered due to Gilbert's syndrome; transaminases <= 3 x ULN.

Exclusion: Concurrent use of other anti-cancer agents or treatments; Malignancies surgically treated with curative intent and with no known active disease present for 3 years before randomization; Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, hypertension, hyperthyroidism or hypothyroidism, etc.); Vaccination with a live vaccine a minimum of 28 days prior to registration; Use of any other experimental drug or therapy within 28 days of baseline; History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemie heart disease) (CTCAE grade 111-IV); Severe neurological or psychiatrie disease (CTCAE grade 111-IV); Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; History of severe allergie or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products; Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B care antibody (anti-HBc); Hepatitis C virus (HCV): Patients with positive hepatitis C serology unless HCV- (RNA) is confirmed negative; HIV positive patients; Active fungal, bacterial, and/or viral infection that requires systemic therapy; Fertile men or women of childbearing potential unless: (1). surgically sterile or >= 2 years after the onset of menopause (2). willing to use a highly effective contraceptive method (Pearl Index <1) during study treatment and in female patients for 18 months after end of antibody treatment and male patients for 6 months after end of treatment; Current inclusion in other clinical trials; Severe pulmonary dysfunction (CTCAE grade 111-IV); Wamen who are pregnant or lactating; lntolerance of exogenous protein administration.

EU CTIS 2024-511048-22-00