drugset
drugset / Trial / NCT06007911

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT06007911 ↗

Phase 1 Withdrawn Medical College of Wisconsin
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label phase I study designed to evaluate the safety of venetoclax-navitoclax with cladribine-based salvage therapy.

Timeline

Start
2024-08-31
Primary completion
2025-12
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Navitoclax Small molecule 25 mg Oral
Subject Navitoclax Small molecule 50 mg Oral
Subject Navitoclax Small molecule 75 mg Oral
Subject Navitoclax Small molecule 100 mg Oral
Subject Venetoclax Small molecule 400 mg Oral
Background Cladribine Small molecule 5 mg/m2 Intravenous
Background Cytarabine Small molecule 20 mg/m2 Subcutaneous
Background Cytarabine Small molecule 1.5 g Subcutaneous
Background Mitoxantrone Small molecule 10 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 300 ug Subcutaneous

Indications

acute myeloid leukemia