drugset
drugset / Trial / NCT04264806

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

NCT04264806 ↗

Phase 2 Withdrawn Janssen Research & Development, LLC argenx · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Timeline

Start
2021-05-06
Primary completion
2022-04-19
Completion
2025-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cusatuzumab Monoclonal antibody 20 mg/kg Subcutaneous
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous

Indications

chronic myelomonocytic leukemia myelodysplastic syndrome