Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 1 July 2021
hematologic disorder
serum bilirubin level


This phase study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.


Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age.

Condition acute myeloblastic leukemia, Acute Myeloid Leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, acute myelogenous leukemia, anll
Treatment Donafenib
Clinical Study IdentifierNCT04402723
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on1 July 2021


Yes No Not Sure

Inclusion Criteria

Patients with diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
Patients with diagnosed Relapsed AML according to Chinese Guidelines for the Diagnosis and Treatment of Acute Myeloid Leukemia
relapse after 6 months of an morphological remission
Age 18 and 55 years
BMI 18 and 27
Informed consent, personally signed and dated to participate in the study
ECOG performance status of 0-1
Life expectancy of at least 12 weeks
Total serum bilirubin 1.5ULN
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) 2.5ULN
Serum creatinine 1.5ULN
glomerular filtration rate 60 mL/min, as calculated with the Cockcroft-Gault formula
alkaline phosphatase 1.5ULN
urine protein 1+, or Urine protein was quantified for 24h 0.5g

Exclusion Criteria

Patients who are not eligible for standard chemotherapy as per discretion of the treating physician
Patients who have been treated with bone marrow transplantation
Central nervous system manifestation of AML
Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Patients who have thrombosis events within 6 months prior to study entry is permitted
Pregnancy or breastfeed
Chronic pulmonary disease with relevant hypoxia
Patients undergoing dialysis
Known HIV and/or hepatitis C infection
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Blood pressure (BP) higher than systolic 140 mmHg and/or diastolic 90 mmHg after best treatment
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance of the protocol
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry is permitted
Serious, non-healing wound, ulcer or bone fracture
Infection need antibiotic treatment
Cumulative therapeutic dose of Daunorubicin more than 300mg/m2
Concurrent malignancies other than AML
History of organ allograft
Allergy to study medication or excipients in study medication
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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