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Chronic Lymphocytic LeukemiaPhase 2NCT06367374

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sonrotoclax and Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
30 May 2024to 30 Jul 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Treatment naïve adult patients with diagnosis of CLL/SLL requiring treatment according to iwCLL guidelines 2018
  • Measurable nodal disease by CT/MRI.
  • Adequate hematologic function
  • Adequate hepatic and renal function
  • Eastern Cooperative Oncology Group
  • (ECOG) performance status of 0-2
  • Expected survival period > 6 months

Who cannot join

  • Any prior systemic therapy used for treatment of CLL/SLL
  • With history of prolymphocytic leukemia, known or currently suspected Richter's transformation
  • Known central nervous system involvement by leukemia or lymphoma
  • Confirmed progressive multifocal leukoencephalopathy (PML)
  • Severe or debilitating pulmonary disease
  • Clinically significant cardiovascular disease
Show all 16Show fewer
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura requiring treatment
  • History of other malignancies
  • Prior therapy with study drugs within 4 weeks before screening
  • Active fungal, bacterial, and/or viral infection requiring systemic therapy
  • Known allergy to zanubrutinib or sonrotoclax or any pharmaceutical excipients
  • Pregnant or lactating women
  • Vaccinated with live vaccines within 28 days prior to enrollment
  • Serologically positive of human immunodeficiency virus (HIVAb), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • History of stroke or intracranial hemorrhage within 6 months
  • Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Shuhua Yi contact

15900265415

yishuhua@ihcams.ac.cn

Yexiang Wang contact

13810279737

yexiang.wang@ashermed.com

About this study

Official title: A Single Arm, Open-label Study of MRD-Guided Zanubrutinib in Combination With Sonrotoclax in Adult Patients With Treatment Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment.

Read the detailed description

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are often considered different variations of the same disease due to their many similarities. There is an urgent need for new treatments to improve patients' quality of life, prolong survival, and manage disease-related symptoms.

There are several different methods for treating front-line therapy, including Chemoimmunotherapy (CIT), Bruton tyrosine kinase inhibitors (BTKis), and BCL-2 inhibitors (BCL2is). Continuous treatment with BTK inhibitors is necessary for the treatment of CLL or SLL. However, younger patients may need to limit their therapeutic duration. The combination of BTK inhibitors and BCL-2 inhibitors is believed to be an optimizing regimen that provides a limited duration of therapy.

The main aim of this study is to assess whether MRD-guided zanubrutinib, in combination with sonrotoclax, can be an effective first-line treatment option for adult patients with treatment-naïve CLL or SLL. The goal is to achieve long-lasting and more profound responses, which could allow for the possibility of discontinuing treatment.

Being tested
Sonrotoclax, Zanubrutinib
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.

  • SonrotoclaxDrug

    Also called BGB-11417

    Participants receive zanubrutinib orally 160mg bid from start of Cycle 1, and in combination with sonrotoclax (SZ) from Cycle 4 onwards at increasing doses until 320mg daily target dose is reached and continuing for at least 12 cycles (each cycle is 28 days).

    Participants with uMRD and PR/CR by the end of Cycle 15 will stop SZ treatment, others will continue to receive SZ for another 12 cycles and stop SZ if uMRD and PR/CR.

    Participants will receive sonrotoclax up to 2 years, and receive zanubrutinib for those with MRD-positive by then.

  • ZanubrutinibDrug

    Also called BGB- 3111

    Participants receive zanubrutinib orally 160mg bid from start of Cycle 1,Participants with uMRD and PR/CR by the end of Cycle 15 will stop SZ treatment, others will continue to receive SZ for another 12 cycles and stop SZ if uMRD and PR/CR.

    Participants will receive sonrotoclax up to 2 years, and receive zanubrutinib for those with MRD-positive by then.

Study groups in NCT06367374
Study groupRoleWhat they receive
Sonrotoclax Plus ZanubrutinibExperimental* Participants will receive from the start of Cycle 1 a standard dose of zanubrutinib twice daily orally for three cycles and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses twice a week until the target dose is reached from Cycle 5 and continuing until the end of Cycle 15 (each cycle is 28 days). Patients with a measurable minimal residual disease (MRD) will receive another 12 cycles of Zanubrutinib in combination with sonrotoclax until their MRD is undetectable. * Interventions: * Drug: Sonrotoclax * Drug: Zanubrutinib
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib

What is being measured

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

  1. 4-Year Progressive Free Survival (PFS) Rate

    PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by investigators

    Measured: 4 years after enrollment

Secondary outcomes (8)

  1. Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD)

    Rate of PB and BM uMRD is defined as proportion of participants achieving remission based on flow cytometry (FCM) result of < 1 CLL cell per 100,000 leukocytes (< 10 ^-4 ), after completion of 12 and 24 cycles of sonrotoclax treatment.

    Measured: At screening, the end of Cycle 14 and Cycle 26 (each cycle is 28 days)

  2. Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate

    CR/CRi rate is defined as the percentage of participants achieving a response of complete response (CR), CR with incomplete blood count recovery (CRi) per 2018 IWCLL criteria, as determined by investigators

    Measured: Up to 4 years

  3. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving a response of complete response (CR), CR with incomplete blood count recovery (CRi), nodular partial response (nPR), partial response (PR), or PR with lymphocytosis (PRL) evaluated under the 2018 IWCLL criteria, as determined byinvestigators

    Measured: Up to 4 years

  4. Duration of Response (DOR)

    DOR was calculated for participants achieving a response (CR, CRi, nPR, PR) based on 2018 IWCLL response criteria in CLL or a response (PR or better) based on 2014 Lugano response criteria and defined as the interval between the date of initial documentation of a response mentioned above until disease progression (PD) or death from any cause, whichever occurred first

    Measured: Up to 4 years

  5. Progression Free Survival (PFS)

    PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by investigators

    Measured: Up to 4 years

  6. Overall Survival (OS)

    OS is defined as time from the date of enrollment to the date of death because of any cause

    Measured: Up to 4 years

  7. Time to Next Therapy (TTNT)

    Time to next CLL or SLL therapy is defined as the time from the first administration of study drugs to the first administration of the next CLL/SLL treatment, as determined by investigators

    Measured: Up to 4 years

  8. Overall survival rate

    Number, time frame and seriousness of participants with Treatment-Emergent Adverse Events (NCI-TEAE v5.0)

    Measured: Up to 4 years

Timeline

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

  1. First posted16 Apr 2024
  2. Study start30 May 2024 (estimated)
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion30 Jul 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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06367374
Sponsor's protocol ID
BGB-11417-2002-IIT；BDH-CLL-004
Status last verified
Apr 2024
First submitted
20 Mar 2024
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sonrotoclax and Zanubrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.

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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Shuhua Yi (15900265415, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4-Year Progressive Free Survival (PFS) Rate (time frame: 4 years after enrollment). 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 NCT06367374.

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 16 Apr 2024.

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Clinical Trial NCT06367374 | AzTrials