This study is being done to compare two standard treatment regimens for acute myeloid leukemia (AML). The first treatment regimen is called DA-90, which involves standard of care drugs daunorubicin (DNR) and Ara-C, is a standard of care upfront treatment regimen for untreated AML. The second treatment regimen is called DAC, which involves standard of care drugs cladribine, daunorubicin, and Ara-C, and is also a standard of care treatment regimen for untreated AML. This phase 3 study hopes to compare the effectiveness and safety of these two upfront regimens.
There is an additional component of this phase 3 study, involving only those subjects for whom the above upfront treatment regimen did not work (did not achieve a complete response [CR]) or their disease relapsed after the treatment. The treatment regimen called CLAG-M, which involves standard of care drugs cladribine, mitoxantrone, G-CSF, and Ara-C, is a standard of care reinduction treatment regimen for AML. The treatment regimen called FLAG-IDA, which involves standard of care drugs fludarabine, idarubicin, G-CSF, and Ara-C, is also a standard of care reinduction treatment regimen for AML. Thus the second aim of this phase 3 study is to compare the effectiveness and safety of these two reinduction regimens for subjects who did not achieve a complete response after the first round of treatment.
This study also hopes to investigate what biological factors of the leukemia determine whether the subjects will respond to treatment and whether it is possible to identify subjects who will particularly benefit from the applied therapeutic program.
None of the drugs involved in this study is experimental or new; all are standard of care drugs and regimens. They work by damaging DNA in leukemic cells (and normal cells) leading to a reduction in the number of leukemic cells in the body.
- Subjects must have a diagnosis of previously untreated acute myeloid leukemia (either AML de novo, AML secondary to myelodysplastic syndromes, or AML secondary towards used therapies or agents which can induce leukemia)
- Subjects must be at least 18 years old and no greater than 60 years old.
- Subjects must have a clinical condition allowing induction treatment to be performed.
- Subjects must have normal liver and kidney function.
*Detailed eligibility criteria will be reviewed when you contact the study team.