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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGRigshospitalet Copenhagen University Hospital
Copenhagen, Denmark
RECRUITINGUniversity Clinical Center Belgrade
Belgrade, Serbia
Safety of Karonudib (TH1579)
Grade and frequency of AE and SAE using the CTCAE version 5.0
Time frame: 28 days, first treatment cycle for the patient.
Tolerability of Karonudib (TH1579)
Grade and frequency of AE and SAE using the CTCAE version 5.0
Time frame: 28 days, first treatment cycle for the patient.
Preliminary signs of clinical efficacy of Karonudib.
ELN/IWG response criteria
Time frame: 28 days, first treatment cycle for the patient.
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Vojnomedicinska akademija, Klinika za hematologiju
Belgrade, Serbia
RECRUITINGUniversity Clinical Center Kragujevac
Kragujevac, Serbia
RECRUITINGKarolinska University Hospital
Huddinge, Sweden
RECRUITINGÖrebro University Hospital
Örebro, Sweden
RECRUITING