Trial intelligence / Profile preview

Daratumumab Plus Ibrutinib in Waldenstrӧm's Macroglobulinemia

NCT03679624Phase 2

Key facts

Status: Terminated
Start: Jul 2020
Primary completion: Sep 2020
Countries: 1
Sponsor: Weill Cornell Medicine
Modality: Recombinant Proteins and Enzymes, Monoclonal Antibodies

Drugs: daratumumab
Conditions: Waldenström's macroglobulinemia (WM)

Overview

Phase 2, open-label trial of daratumumab in Waldenström's macroglobulinemia (WM) (2 cohorts), sponsored by Weill Cornell Medicine. Primary endpoint: Safety of Combination Treatment With Ibrutinib and Daratumumab at 3 months. Started Jul 2020; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort A - Ibrutinib naive
Ibrutinib + Daratumumab
Cohort B - Ibrutinib response plateau
Ibrutinib + Daratumumab

Who it enrols

Patients with Waldenstrӧm's macroglobulinemia who are either ibrutinib-naïve (Cohort A) or have plateaued on ibrutinib (Cohort B). Must have measurable disease and adequate organ function.

Endpoints

Primary

Safety of Combination Treatment With Ibrutinib and Daratumumab3 months

Secondary

Major Response Rate in Cohort A5 years
Deepening of Response Rate in Cohort B After Daratumumab Addition5 years
Duration of Response5 years
Time to Progression5 years
Progression Free Survival3 months
Overall Survival3 months

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