The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile. Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R. Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Oshadi D (180mg/TID) \& Oshadi R (180mg TID) will be administrated;
Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
Time frame: 28 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.