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Chronic Lymphocytic LeukemiaPhase 2BRAVENCT06524375

A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period

A Phase 2 study testing Venetoclax and cBTKi Monotherapy in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 20 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Venetoclax and cBTKi Monotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
20 sitesUnited States
Study dates
9 Aug 2024to 31 Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2
  • Adequate renal and liver function

Who cannot join

  • Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  • Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
  • Progressive or stable disease on cBTKi
  • Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  • History of cardiomyopathy
  • Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
Show all 10Show fewer
  • Clinically significant cardiovascular disease
  • Active bleeding or history of bleeding diathesis
  • Pregnant women and nursing mothers
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Rocky Mountain Cancer Centers (Aurora) - USOR

    Aurora, Colorado, 80012-5405

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817-1915

  • Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center

    Boston, Massachusetts, 02215-5418

  • Tennessee Oncology, PLLC - Chattanooga

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care Inc - Cincinnati - USOR

    Cincinnati, Ohio, 45236-2725

  • Ohio State University

    Columbus, Ohio, 43210

  • Mission Blood and Cancer - MercyOne Cancer Center

    Des Moines, Iowa, 50314-3030

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816-4096

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401-6043

  • San Juan Oncology Associates, PC

    Farmington, New Mexico, 87401

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804

  • Nebraska Cancer Specialists St Francis - Grand Island

    Grand Island, Nebraska, 68803

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256-6932

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504-8332

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology - Midtown

    Nashville, Tennessee, 37203

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: Phase II, Open-label, Prospective Single-arm, Multi-center Clinical Trial to Evaluate if Adding Venetoclax to Patients on Covalent BTKi For 1L CLL Can Achieve Deep Durable Remissions (by UMRD 10^-4) to Allow Off-treatment Period

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.

The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

Being tested
Venetoclax, cBTKi Monotherapy
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called RO5537382

    Venetoclax tablets will be administered as per the schedule specified in the arm.

  • cBTKi MonotherapyDrug

    Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.

Study groups in NCT06524375
Study groupRoleWhat they receive
Venetoclax Added to cBTKi (Commercially Prescribed)ExperimentalParticipants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (< 10^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label.
Receives: Drug: Venetoclax; Drug: cBTKi Monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. uMRD4 Rate at EOCT

    uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10^-4) from PB.

    Measured: Cycle 12 Day 28 (Cycle length= 28 Days)

Secondary outcomes (11)

  1. CR/CRi Rate at EOCT as Determined by the Investigator According to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines

    Complete response (CR)/complete response with incomplete recovery of the bone marrow (CRi) rate is defined as the percentage of participants with a CR or CRi at EOCT, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 12 months

  2. PR Rate at EOCT as Determined by the Investigator According to iwCLL Guidelines

    PR rate is defined as the percentage of participants with a PR at EOCT, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 12 months

  3. Overall Response Rate (ORR) at EOCT as Determined by the Investigator According to iwCLL Guidelines

    ORR is defined as the percentage of participants with a CR/CRi or PR at EOCT, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 12 months

  4. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE and SAEs will be collected as part of this study at baseline and every clinical visit, until 30 days after the final dose of study treatment.

    Measured: Up to approximately 13 months

  5. Number of Participants Who Withdrew Prematurely from the Study

    Participants who discontinued treatment before Cycle 12 Day 28 (cycle length= 28 days).

    Measured: Up to approximately 12 months

  6. Overall Survival (OS)

    OS is defined as the time from the first study treatment to death from any cause.

    Measured: Up to approximately 48 months

  7. Progression-free Survival (PFS) as Determined by the Investigator According to iwCLL Guidelines

    PFS is defined as the time from the first study treatment to the first occurrence of disease progression (PD) or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 48 months

  8. Event-free Survival (EFS) as Determined by the Investigator According to iwCLL Guidelines

    EFS is defined as the time from the first study treatment to the first occurrence of PD, anti-leukemic treatment subsequent to the study treatment, or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 48 months

  9. Duration of Response (DOR) in Participants With CR/CRi or PR as Determined by the Investigator According to iwCLL Guidelines

    DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR/CRi or PR) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 12 months

  10. DOR in Participants With CR or CRi as Determined by the Investigator According to iwCLL Guidelines

    DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR or CRi ) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.

    Measured: Up to approximately 12 months

  11. Time to Next CLL Treatment (TTNT)

    TTNT is defined as the time from the first study treatment to the start of anti-leukemic treatment subsequent to the study treatment or death, whichever occurs first.

    Measured: Up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start9 Aug 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524375
Sponsor's protocol ID
ML45219
Acronym
BRAVE
Status last verified
Sep 2026
First submitted
23 Jul 2024
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax and cBTKi Monotherapy in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

uMRD4 Rate at EOCT (time frame: Cycle 12 Day 28 (Cycle length= 28 Days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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