Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Exclusion Criteria

• •4. White blood cell (WBC) ≤ 10 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2 days before start cladribine treatment)
• •5. Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
• •* Serum creatinine ≤ 221.7 µmol/L (≤ 2.5 mg/dL ), unless considered AML-related -Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML-
• •* related or due to Gilbert's syndrome
• •* Alanine transaminase (ALT) ≤ 2.5 x ULN, unless considered AML-related
• •6. WHO performance status 0, 1 or 2.
• •7. Patient is willing and able to use adequate contraception during and until 5 months after the last protocol treatment.
• •8. Written informed consent.
• •9. Patient is capable of giving informed consent.
• •1. Acute promyelocytic leukemia.
• •2. Acute leukemia's of ambiguous lineage according to WHO 2016
• •3. Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
• •4. Blast crisis of chronic myeloid leukemia.
• •5. Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
• •6. except when the patient completed successfully treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization. OR
• •7. except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• •8. Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period ( ≤ 5 days) with Hydroxyurea is allowed
• •9. Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
• •10. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
• •11. Cardiac dysfunction as defined by:
• •* Myocardial infarction within the last 3 months of study entry, or
• •* Reduced left ventricular function with an ejection fraction \< 40% as measured by MUGA scan or echocardiogram or
• •* Unstable angina or
• •* New York Heart Association grade IV congestive heart failure or
• •* Unstable cardiac arrhythmias.
• •12. History of stroke or intracranial hemorrhage within 6 months prior to randomization.
• •13. Patient has a history of human immunodeficiency virus or active infection with Hepatitis C or B.
• •14. Patients known to be pregnant
• •15. Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.
• •16. Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
• •17. Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
• •18. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule