The study investigates the effect and safety of ivosidenib and enasidenib in patients with AML or MDS-EB2 and an IDH1 or IDH2 mutation. We want to find out whether the disease can be controlled more effectively and for longer by administering the new drug in addition to standard treatment with chemotherapy.
Aim of the study
The study investigates the effect and safety of ivosidenib and enasidenib in patients with AML or MDS-EB2 and an IDH1 or IDH2 mutation. We want to find out whether the disease can be controlled more effectively and for longer by administering the new drug in addition to standard treatment with chemotherapy.
Who can take part?
Patients with untreated acute myeloid leukemia (AML) or previously untreated advanced myelodysplastic syndrome (MDS-EB2) with IDH1 or IDH2 mutation.
Procedure
The individual treatment takes about 2.5 years in total. As part of this study, you will be followed up for a period of 10 years after the start of treatment.
The first phase of treatment, induction therapy, consists of two consecutive cycles of various forms of chemotherapy. During the induction cycles, chemotherapy is combined with either ivosidenib or a placebo (in the case of an IDH1 mutation) or with enasidenib or a placebo (in the case of an IDH2 mutation).
Once the first phase has been completed, an assessment will be made as to whether you are eligible for the second phase (consolidation therapy). There are three possible treatments:
- Chemotherapy in combination with ivosidenib or placebo (for an IDH1 mutation) or with enasidenib or placebo (for an IDH2 mutation).
- Chemotherapy with stem cell transplantation using your own stem cells.
- Chemotherapy with stem cell transplantation using stem cells from a donor.
In the third phase of treatment, known as maintenance therapy, you will take ivosidenib or placebo (for an IDH1 mutation) or enasidenib or placebo (for an IDH2 mutation) as tablets for two years.
Before, during and after the study, your state of health will be examined regularly. At the follow-up appointments, a blood sample is taken for laboratory tests and, if necessary, further examinations. Bone marrow examinations are carried out regularly. On the one hand, to be able to assess the response to the medication and, on the other, to determine the further therapy.
Compensation
Original study name
A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia
BASEC number
2019-01281
Sponsors