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Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

ConditionsChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaRecurrent Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3a Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Nodal Marginal Zone LymphomaRecurrent Splenic Marginal Zone LymphomaRefractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueRefractory Grade 1 Follicular LymphomaRefractory Grade 2 Follicular LymphomaRefractory Grade 3a Follicular LymphomaRefractory Mantle Cell LymphomaRefractory Nodal Marginal Zone LymphomaRefractory Splenic Marginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin 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 on the day of signing the informed consent form

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Disqualifiers

Major surgery ≤ 4 weeks of the first dose of study drug

Prior autologous stem cell transplant unless ≥ 30 days after transplant; or prior chimeric antigen receptor T cell (CAR-T) therapy unless ≥ 30 days after cell infusion

Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent

Prior therapy ≥ 2 months with or progression on a Bcl2 inhibitor (eg, venetoclax)

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo urine and 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

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Sonrotoclax

    Drug

    Given PO

  • Zanubrutinib

    Drug

    Given PO

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Treatment (zanubrutinib, sonrotoclax)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Feasibility of completing zanubrutinib lead-in (cycle 1 and cycle 2) and sonrotoclax ramp up (cycle 3)

Will be estimated as a binary proportion along with the 95% exact binomial confidence interval.

Time frame
From start of cycle 1 through end of cycle 3 (cycle length = 28 days)
2

Feasibility of patient retention through 2 cycles of the combination therapy at a steady dose

Will be estimated as a binary proportion along with the 95% exact binomial confidence interval.

Time frame
From start of cycle 4 though end of cycle 5 (cycle length = 28 days)

Secondary outcomes

1

Incidence of adverse events (AEs)

Will be coded and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. For chronic lymphocytic leukemia/small lymphocytic leukemia, hematologic AEs will be coded and graded by International Workshop on Chronic Lymphocytic Leukemia.

Time frame
Up to 30 days after last dose of study treatment
2

Overall response rate

Will be defined as achieving a best response of complete response (CR) or partial response (PR). Will be calculated as the proportion of response-evaluable participants achieving an overall response. Will be estimated as a binary proportion along with the 95% exact binomial confidence interval.

Time frame
After the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy, assessed up to 3 years
3

CR rate

Will be defined as achieving a best response of CR. CR rate will be calculated as the proportion of response-evaluable participants achieving CR. Will be estimated as a binary proportion along with the 95% exact binomial confidence interval.

Time frame
After the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy, assessed up to 3 years
4

Time to response

Will be summarized by descriptive statistics.

Time frame
From start of protocol treatment to the time CR or PR is first achieved, 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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