At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Venetoclax (drug), Acalabrutinib (drug), Obinutuzumab (drug)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Venetoclax — drug: Oral: Tablet · Acalabrutinib — drug: Oral: Tablet · Obinutuzumab — drug: Intravenous Infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the risk of a condition called tumour lysis syndrome (TLS) in adults with chronic lymphocytic leukaemia (CLL), a type of blood cancer, who have not had treatment before. TLS can happen when cancer cells break down quickly. The study is funded by AbbVie.
Who can take part
- You have been diagnosed with chronic lymphocytic leukaemia (CLL) that has not been treated before, and your doctor says you need treatment based on 2018 international guidelines. You must have a life expectancy of more than 6 months.
- People with small lymphocytic lymphoma (SLL) that has not been treated before and needs treatment under the same guidelines can also take part.
- You can carry out day-to-day activities at least half the time (performance status of 2 or less on a scale used by doctors).
- Your bone marrow is working well enough on its own, without growth factor injections or blood transfusions in the 2 weeks before screening, unless problems are caused by the leukaemia itself.
- Your kidneys filter waste at a rate of at least 30 mL/min (measured with a test called creatinine clearance).
Who may not be able to
- You have an active or uncontrolled infection.
- You have Richter's transformation (where the leukaemia changes into a faster-growing type of cancer).
- You have active immune thrombocytopenia (a condition where the immune system destroys platelets, which help blood to clot).
What taking part involves
- • Taking venetoclax as a tablet by mouth.
- • Either having obinutuzumab given through a drip into a vein (an infusion), or taking acalabrutinib as a tablet by mouth.
Time commitment: How long the study lasts and how many visits are needed is not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 170
- Started
- 2024-08-05
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase3 - 170 participants
- • Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Nottingham - Nottingham City Hospital /ID# 266991
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be...
- ✓activity scale (ECOG) performance status \<= 2.
- ✓healthy marrow independent of growth factor or transfusion support within 2 weeks of screening, unless...
- ✓Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.
Who cannot take part
- ✗\- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
See the full criteria
Where Is This Study? (1 UK site)
Nottingham City Hospital /ID# 266991
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
Sponsor contactCONTACT