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A Study in Leukemia Patients With Karonudib — MAATEO  

Leukemia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04077307
Study type Interventional
Source Thomas Helleday Foundation
Contact Maria Klockare, BSc
Phone +46706232505
Email maria.klockare@oxcia.com
Status Recruiting
Phase Phase 1
Start date December 3, 2019
Completion date January 30, 2026
View Details
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