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Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

ConditionsChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Woyach

About this trial

This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. 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. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of CLL/SLL meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines

Is an individual of any sex/gender, who is at least 18 years of age on the day of signing informed consent

Participants must have treatment-naïve CLL/SLL. Palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptom control will not be considered prior therapy

Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly

Disqualifiers

Subject with other malignancies that are associated with a life expectancy of < 2 years or that would confound assessment of toxicity in this study.

NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder

Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study

Active HBV/HCV infection

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Nemtabrutinib

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Venetoclax

    Drug

    Given PO

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (nemtabrutinib and venetoclax)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Presence of undetectable minimal residual disease (MRD)

As measured by Adaptive ClonoSeq next generation sequencing at a level of 10\^-6 in the peripheral blood after 14 cycles of treatment with nemtabrutinib and venetoclax. The rate of undetectable MRD will be calculated in all eligible patients who start any amount of study drug, and the 95% confidence interval will be provided with the estimated rate.

Time frame
After 14 cycles of treatment (cycle length = 28 days)

Secondary outcomes

1

Incidence of adverse events

Toxicities will be captured by Common Terminology Criteria for Adverse Events version 5 for nonhematologic and skin toxicities and iwCLL guidelines for hematologic toxicities. The maximum grade for each type of toxicity will be tabulated for each patient, and frequency tables will be reviewed to determine toxicity patterns. Will assess adverse events of all grades with a focus on grade 3 or higher toxicity. Adverse events regardless of attribution will be summarized first, and those attributable to study drug will also be listed separately. The incidence of serious adverse events or those of special interest will be described. To assess tolerability, will also capture the proportion of patients who go off treatment due to adverse events.

Time frame
Up to 1 year
2

Progression free survival (PFS)

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

Time frame
From date of treatment start to progression or death, whichever occurs first, assessed up to 1 year
3

Time to next treatment

Will be estimated using cumulative incidence function, with death without next treatment being the competing risk and censoring patients who are still on study treatment or alive after going off treatment at time of last follow-up.

Time frame
From study treatment start to the date the next treatment starts, assessed up to 1 year
4

Response to treatment

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

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

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

Jennifer Woyach

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: