drugset / Trial / NCT04230304

Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study

NCT04230304 ↗

Phase 2 Terminated 8 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well daratumumab and ibrutinib work in treating patients with chronic lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Daratumumab is a monoclonal antibody which works with the body's immune system to destroy cancer cells. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with chronic lymphocytic leukemia compared to ibrutinib alone.

Timeline

Start
2020-11-11
Primary completion
2023-05-01
Completion
2025-02-13

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody — Intravenous
Subject Ibrutinib Small molecule — Oral