Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPETHEMA Foundation
About this trial
The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are:
* Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment. * Determine the incidence and severity of all adverse events (AEs).
All participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR/CRi will be elegible to receive allogeneic stem cell transplantation.
Eligibility criteria
Qualifiers
Morphological diagnosis of AML (WHO criteria 2022)
Newly diagnosed AML.
IDH1 R132 mutations (centrally assessed by PCR and NGS). A patient will be allowed to be included with local result after approval of the medical monitor.
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 if ≥ 60 years of age, or 0 to 3 if ≥ 18 to 60 years.
Disqualifiers
Subject has history of myeloproliferative neoplasm [MPN] with BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
Prior therapy for AML (except hydroxiurea).
Genetic diagnosis of acute promyelocytic leukemia.
Subject is known to be positive for HIV (HIV testing is not required.)
Trial design
Treatments tested in this trial
- Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET
- Ivosidenib Oral Tablet
- Hydroxyurea
- Cytarabine
- Allogeneic stem cell transplantation
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov