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HO182 CLL: Treatment of patients with chronic lymphocytic leukemia (CLL) with 6 cycles of rituximab in combination with 6 or 26 cycles of venetoclax upon recurrence of the disease after previous treatment
EU CTIS ID: 2025-524283-38-00
What this study is testing
To compare progression free survival (PFS) from the time of randomization between continuation of treatment with venetoclax for 20 cycles (Arm A) versus discontinuation of treatment (Arm B), in patients treated with 6 cycles Ven-R.
- Therapeutic confirmatory (Phase III)
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 or refractory CLL or SLL following at least one systemic 1st-line treatment.
- TP53 mutation status tested after last treatment.
- Del17p mutation status tested after last treatment.
- Patient is able and willing to adhere to the study visit schedule and other protocol requirements.
- Written informed consent.
- Patient is capable of giving informed consent.
You likely can't join if
- Transformation of CLL (Richter’s transformation).
- Active treatment with anti-neoplastic drugs in another clinical trial.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patient received prior venetoclax treatment within 24 months of registration OR patient had progressed during previous venetoclax treatment.
- Patient with central nervous system involvement.
- Malignancies other than CLL/SLL currently requiring systemic therapy, not treated with curative intent, or showing signs of progression after curative treatment.
See the full eligibility criteria
Who can join
- Documented relapsed or refractory CLL or SLL following at least one systemic 1st-line treatment.
- TP53 mutation status tested after last treatment.
- Del17p mutation status tested after last treatment.
- Patient is able and willing to adhere to the study visit schedule and other protocol requirements.
- Written informed consent.
- Patient is capable of giving informed consent.
- Requiring treatment according to IWCLL 2018 criteria.
- Age at least 18 years.
- WHO performance status 0-3; stage 3 only if attributable to CLL/SLL.
- Adequate BM function defined as: Hemoglobin (Hb) > 5.0 mmol/l, unless low Hb is directly attributable to CLL/SLL infiltration of the BM; Absolute neutrophil count (ANC) > 0.75 x 109/L (1,000/μL), unless low ANC is directly attributable to CLL/SLL infiltration of the BM; Platelet count > 30 x 109/L (30,000/μL), unless low platelets is directly attributable to CLL/SLL infiltration in the BM.
- Estimated Glomerular Filtration Rate (eGFR) (MDRD) or estimated creatinine clearance (CrCl) ≥ 30ml/min (Cockcroft-Gault).
- Adequate liver function as indicated: serum aspartate transaminase (ASAT) and alanine transaminase (ALAT) ≤ 3.0 x upper limit of normal (ULN); bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or controlled autoimmune hemolytic anemia).
- Negative serological testing for hepatitis B virus (Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) negative) and hepatitis C virus (hepatitis C antibody). Patients who are positive for anti-HBc, HBsAg, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
- IGHV mutation status assessed at least once.
What rules you out
- Transformation of CLL (Richter’s transformation).
- Active treatment with anti-neoplastic drugs in another clinical trial.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patient received prior venetoclax treatment within 24 months of registration OR patient had progressed during previous venetoclax treatment.
- Patient with central nervous system involvement.
- Malignancies other than CLL/SLL currently requiring systemic therapy, not treated with curative intent, or showing signs of progression after curative treatment.
- Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML).
- Known allergy to xanthine oxidase inhibitors and/or rasburicase.
- History of drug-specific hypersensitivity or anaphylaxis to any study drug.
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease) (CTCAE grade III-IV).
- Severe pulmonary dysfunction (CTCAE grade III-IV).
- Severe neurological or psychiatric disease (CTCAE grade III-IV).
- Active fungal, bacterial, and/or viral infection that requires systemic therapy.
- Patient with Child Pugh C.
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.).
- Patient known to be HIV-positive.
- Patient who has difficulty with or are unable to swallow oral medication, or have significant gastrointestinal disease that would limit absorption of oral medication.
- Pregnant women and nursing mothers.
- 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 such as oral contraceptives, intrauterine device or sexual abstinence during study treatment and for 30 days after last dose of venetoclax and/or 12 months after the last dose of rituximab.
- Previous participation in the HO139 CLL or HO140 CLL trial, and eligible for and willingness to participate in the HO159 CLL trial.
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.