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Nemtabrutinib, Bortezomib, and Rituximab for WM

ConditionWaldenstrom Macroglobulinemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

This is a phase II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of nemtabrutinib in combination with bortezomib and rituximab

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of WM in accordance with the consensus panel of the IWWM (per local evaluation), and treatment naïve

Symptomatic disease meeting at least 1 of the recommendations from the IWWM for requiring treatment.

Measurable disease defined as serum monoclonal IgM > 0.5g/dL.

Is an individual of any sex/gender, who are at least 19 years of age on the day of signing informed consent (ICF).

Disqualifiers

Active HBV/HCV infection.

Positive for human immunodeficiency virus (HIV).

Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).

Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course.

Trial design

Design model

Single group

Treatments tested in this trial

  • NEBULA

    Drug

    Nemtabrutinib + Bortezomib + Rituximab

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: Treatment (NEBULA: Nemtabrutinib + Bortezomib + Rituximab) armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major response rate (MRR)

Composite of complete response (CR) + very good partial response (VGPR) + partial response (PR) according to International Workshop on WM (IWWM)-11 response criteria

Time frame
At the end of Cycle 6 (each cycle is 28 days)

Secondary outcomes

1

Progression-free survival (PFS)

Time from enrollment to first documentation of disease progression or death due to any cause, whichever occurs first

Time frame
through study completion, an average of 2 years
2

Overall survival

Time from enrollment to death from any cause

Time frame
through study completion, an average of 2 years
3

Overall response rate (ORR)

Composite of CR + VGPR + PR + minor response (MR) according to IWWM-11 response criteria

Time frame
At the end of Cycle 24 (each cycle is 28 days)
4

complete response (CR) rate

Response assessments will be based on the IWWM-11 criteria

Time frame
At the end of Cycle 6 and Cycle 24 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

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

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov

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