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GIVE trial (Gazyvaro In combination with VEnetoclax in Elderly CLL)
EU CTIS ID: 2024-511048-22-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Current inclusion in other clinical trials
- Concurrent use of other anti-cancer agents or treatments
- 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
- Malignancies surgically treated with curative intent and with no known active disease present for 3 years before randomization
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
See the full eligibility criteria
- 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
- Current inclusion in other clinical trials
- Concurrent use of other anti-cancer agents or treatments
- 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
- Malignancies surgically treated with curative intent and with no known active disease present for 3 years before randomization
- 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 pulmonary dysfunction (CTCAE grade 111-IV)
- Severe neurological or psychiatrie disease (CTCAE grade 111-IV)
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, hypertension, hyperthyroidism or hypothyroidism, etc.)
- Wamen who are pregnant or lactating
- lntolerance of exogenous protein administration
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.