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A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in physically fit patients with creatinine clearance ≥ 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations, HOVON 141 CLL / VIsion Trial of the HOVON and Nordic CLL study groups
EU CTIS ID: 2023-510557-42-00
What this study is testing
Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for progression free survival (PFS) at 12 months after stopping therapy (27 months after starting treatment) for patients randomized to stop treatment (arm B of the study), reinitiated treatment due to MRD positivity not considered progression
- 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
- Documented relapsed/refractory CLL or SLL requiring treatment according to IWCLL criteria (no limits on previous treatment lines; CD20 and steroids are not considered prior therapy lines)
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
- Written informed consent
- Age at least 18 years
- Adequate bone marrow function, unless directly attributable to CLL infiltration of the bone marrow, proven by bone marrow biopsy
- Creatinine clearance (CrCL) ≥ 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection.
You likely can't join if
- Any prior therapy with ibrutinib and/or venetoclax
- Major surgery within 28 days prior to registration
- Use of investigational agents which might interfere with the study drug within 28 days prior to registration
- Vaccination with live vaccines within 28 days prior to registration
- Steroid therapy within 7 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 25 mg of prednisolone daily to control autoimmune phenomenon’s, or replacement/stress corticosteroids
- Pregnant women and nursing mothers
See the full eligibility criteria
- Documented relapsed/refractory CLL or SLL requiring treatment according to IWCLL criteria (no limits on previous treatment lines; CD20 and steroids are not considered prior therapy lines)
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
- Written informed consent
- Age at least 18 years
- Adequate bone marrow function, unless directly attributable to CLL infiltration of the bone marrow, proven by bone marrow biopsy
- Creatinine clearance (CrCL) ≥ 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection.
- Adequate liver function as indicated
- Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last dose), negative testing for hepatitis C RNA within 42 days prior to registration
- Male and female subjects of reproductive potential must agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of study drug.
- Negative pregnancy test at study entry (for women of childbearing potential)
- WHO/ECOG performance status 0-3 stage 3 only if attributable to CLL
- Any prior therapy with ibrutinib and/or venetoclax
- Major surgery within 28 days prior to registration
- Use of investigational agents which might interfere with the study drug within 28 days prior to registration
- Vaccination with live vaccines within 28 days prior to registration
- Steroid therapy within 7 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 25 mg of prednisolone daily to control autoimmune phenomenon’s, or replacement/stress corticosteroids
- Pregnant women and nursing mothers
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Transformation of CLL (Richter’s transformation)
- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML)
- Malignancies other than CLL currently requiring systemic therapies or not being treated in curative intention before or showing signs of progression after curative treatment
- Known allergy to xanthine oxidase inhibitors and/or rasburicase if no other appropriate prevention of tumorlysis is considered feasible by the treating physician
- Known bleeding disorders (e.g., von Willebrand’s disease or hemophilia)
- Uncontrolled or active infection
- Patients requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists. Please note: Patients being treated with NOACs can be included, but must be properly informed about the potential risk of bleeding under treatment with ibrutinib
- History of stroke or intracranial hemorrhage within 6 months prior to registration
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.