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Looking for participantsPhase2

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Sponsor: AbbVie

NCT ID: NCT04895436

View on ClinicalTrials.gov ↗

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), Obinutuzumab (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
Venetoclax — drug: Oral tablet · Obinutuzumab — drug: Intravenous (IV) infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is for adults whose chronic lymphocytic leukaemia (CLL) — a type of blood cancer — has come back after earlier treatment. It looks at how well oral venetoclax (a tablet) works alongside intravenous (IV, given into a vein) obinutuzumab, and at any side effects. The study is run by AbbVie.

Who can take part

  • You have a confirmed diagnosis of CLL that needs treatment, based on accepted 2018 guidelines.
  • You finished a first course of treatment that included venetoclax plus another antibody medicine (with or without an extra drug), and it worked — your cancer got better.
  • A certain amount of time has passed since your last venetoclax dose and your disease coming back: more than 24 months for one group, or 12 to 24 months for another group.

Who may not be able to

  • You have had any other treatment for CLL since finishing your earlier venetoclax-based treatment.

What taking part involves

  • • Taking venetoclax as a tablet by mouth
  • • Receiving obinutuzumab through a drip into a vein (IV)

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.

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
75
Started
2022-03-28
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia (cll)
  • • Phase2 - 75 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 (cll)

Where?

  • • Blackpool - Blackpool Victoria Hospital /ID# 267280
  • • Norwich - Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
  • • Leeds - Leeds Teaching Hospitals NHS Trust /ID# 250732

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 retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. 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.

Chronic Lymphocytic Leukemia (CLL)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

Biomarkers mentioned

CD20

What the study is looking for

  • ✓Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to...
  • ✓More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease...

Who cannot take part

  • ✗\- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody...
See the full criteria
Inclusion Criteria: * Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria. * Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission. * More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment. Exclusion Criteria: \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Where Is This Study? (3 UK sites)

Blackpool Victoria Hospital /ID# 267280

Blackpool FY3 8NR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Leeds Teaching Hospitals NHS Trust /ID# 250732

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02