drugset / Trial / NCT03679624
Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia
Phase 2
Terminated
1 enrolled
Weill Medical College of Cornell University
Janssen Scientific Affairs, LLC · collabMayo Clinic · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will comprise of patients who are currently receiving ibrutinib but whose response to treatment has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to deepen response.
Timeline
- Start
- 2020-07-30
- Primary completion
- 2020-09-15
- Completion
- 2020-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Background | Ibrutinib | Small molecule | 420 mg | Oral |