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Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

ConditionsChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKerry Rogers

About this trial

This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Giving venetoclax in combination with SOC zanubrutinib may be safe and tolerable and may reduce the number of cancer cells that remain in the body in patients with CLL or SLL that have not previously received treatment or at least two years have passed since completing initial treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of CLL/SLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

Age ≥ 18 years

Indications for treatment as defined by the iwCLL 2018 Guidelines

Received prior treatment or not depending on cohort

Disqualifiers

Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment

Frontline arm only: Patients with deletion 17p and/or TP53 mutation

Active Richter's transformation

Prior zanubrutinib exposure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Venetoclax

    Drug

    Given PO

  • Zanubrutinib

    Drug

    Given PO

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: Cohort I (SOC zanubrutinib, venetoclax)Experimental treatment 7 interventions
Group B: Cohort II (SOC zanubrutinib, venetoclax)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Rate of undetectable minimal residual disease (uMRD) (Firstline Cohort)

Will be defined as \< 1 x 10\^-4 by ClonoSEQ in the peripheral blood, after 12 cycles of combined venetoclax plus zanubrutinib assessed by ClonoSEQ. Will be calculated separately in each cohort among all eligible patients who start any amount of study drug, and the 95% exact confidence interval will be provided with the estimated rate.

Time frame
At end of cycle 15 (cycle length = 28 days)
2

Rate of uMRD (Second Line Cohort)

Will be defined at \< 1 x 10\^-4 by ClonoSEQ in the peripheral blood, after 24 cycles of combined venetoclax plus zanubrutinib. Will be calculated separately in each cohort among all eligible patients who start any amount of study drug, and the 95% exact confidence interval will be provided with the estimated rate.

Time frame
At end of cycle 27 (cycle length = 28 days)

Secondary outcomes

1

Overall response rate (Frontline Cohort)

Will be calculated separately in each cohort among all eligible patients who start any amount of study drug, and the 95% exact confidence interval will be provided with the estimated rate.

Time frame
Up to 5 years
2

Rate of complete remission (Frontline Cohort)

Will be calculated separately in each cohort among all eligible patients who start any amount of study drug, and the 95% exact confidence interval will be provided with the estimated rate.

Time frame
Up to 5 years
3

Duration of clinical response (Frontline Cohort)

The method of Kaplan-Meier will be used to estimate.

Time frame
From date of achieving response to progression or death, assessed up to 5 years
4

Duration of uMRD if achieved (Frontline Cohort)

The method of Kaplan-Meier will be used to estimate.

Time frame
From date of achieving uMRD to progression or death, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kerry Rogers

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

AbbVie

Collaborator

Source ClinicalTrials.gov
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