A study to evaluate the safety and efficacy of mebendazole in combination with low-dose Ara-C in elderly patients with relapsed/refractory acute myeloid leukemia (MAIL)

Prior treatment

• Persistence of toxicity of prior chemotherapy above grade 1
• Prior treatment with low dose Ara-C
• Treatment with any investigational agents within a clinical trial in the last four weeks

Other illness

• Central nervous system (CNS) disease
• Acute or chronic liver diseases with elevated liver enzymes above grade 1

Lab values

• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

Other

• Intolerance against components of mebendazole or cytarabine formulations (especially E110)

• Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
• Relapsed/refractory disease after standard therapy
• Blast concentration in peripheral blood of > 1000/μl
• Men and women aged >70 years, ineligible for intensive treatment (standard dose)
• Ability to swallow and retain oral medication, no known malabsorption syndrome, adequate organ function
• Ability to understand and provide signed informed consent