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Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma

ConditionsConjunctival Mucosa-Associated Lymphoid Tissue LymphomaGastric Mucosa-Associated Lymphoid Tissue LymphomaMarginal Zone LymphomaNodal Marginal Zone LymphomaSplenic Marginal Zone LymphomaLymphomaExtranodal Marginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib in combination with rituximab may be safe, tolerable and/or effective in treating patients with marginal zone lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Disqualifiers

Evidence of diffuse large B-cell lymphoma (DLBCL) transformation

Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL

History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease

Active graft versus host disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nemtabrutinib

    Drug

    Given PO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Rituximab

    Biological/Vaccine

    Given IV

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment (nemtabrutinib, rituximab)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of unacceptable toxicity (Safety lead-in)

Observed toxicities will be summarized by type, severity, and attribution.

Time frame
During cycle 1 (cycle length = 28 days)
2

Complete response (CR) rate (Phase 2)

Will be defined as achieving a best response of CR at any time on the study prior to any disease progression or start of other non-protocol anti-lymphoma therapy. CR rate will be estimated along with the 95% exact binomial confidence interval.

Time frame
Up to 3 years

Secondary outcomes

1

Overall response rate (ORR)

Will be defined as achieving a best response of either CR or partial response (PR) any time on the study prior to any disease progression or start of other anti-lymphoma therapy. ORR will be estimated along with the 95% exact binomial confidence interval.

Time frame
Up to 3 years
2

Progression-free survival (PFS)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when possible.

Time frame
From start of protocol treatment to disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 3 years
3

Duration of response (DOR)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when possible.

Time frame
From the first achievement of PR or CR to the time of disease relapse/progression or death due to any cause, whichever earlier, assessed up to 3 years
4

Overall survival (OS)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, 95% confidence interval will be constructed based on log-log transformation. Median OS will be estimated when possible.

Time frame
From start of protocol treatment to death due to any cause, assessed up to 3 years

Other outcomes

Sponsors and contacts

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

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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