NCT04077307

A Study in Leukemia Patients With Karonudib

A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Thomas Helleday Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

Detailed description

Primary Objective Part I * To determine the safety and tolerability of Karonudib in escalating doses for the treatment of patients with advanced relapsed/refractory Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) , Diffuse Large B-Cell Lymphoma, Multiple Myeloma (MM) and high-risk Myelodysplastic Syndrome (MDS)AML, ALL, DLBCL, Burkitt´s lymphoma, multiple myeloma and high-risk MDS Primary Objective Part II * To determine the safety and tolerability of Karonudib in combination with standard of care treatment, Idarubicinother anti-cancer agents for the treatment of patients with advanced progressive, relapsed/refractory AML, and high-risk MDS

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Karonudib	First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.

Timeline

• Start date: 2019-12-03
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2019-09-04
• Last updated: 2025-12-19

Locations

6 sites across 3 countries: Denmark, Serbia, Sweden