NCT07507760

Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients

A Phase II, Multicentre, Open Label Clinical Trial Evaluating the Efficacy and Safety of Oral Decitabine Plus Ivosidenib in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia Older Than 60 Years Old and/or Who Are Ineligible for Standard Induction Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A total of 50 participants will be assigned to the single treatment arm which will have treatment cycles of 28 days with Ivosidenib 500 mg/orally on Days 1-28 plus oral decitabine-cedazuridine (one tablet once daily containing 35 mg decitabine and 100 mg cedazuridine as a fixed-dose combination) on days 1-5. Hydroxiurea or maximum 1 gram/sqm of cytarabine is allowed to control hyperleukocytosis during the screening period as well as during the first two cycles of induction. Participants will continue their study treatment until documented disease progression per Investigator assessment, unacceptable toxicity, withdrawal of consent, the subject meets other protocol criteria for discontinuation or study completion (whichever occurs first). Participants who are considered eligible for an allogeneic stem cell transplant after achieving CR/CRi will perform a pre-transplant visit into the study, collecting MRD stats and characteristics of transplant. They will be allowed to resume ivosidenib after day +60 of transplant. The post-transplant schedule can be administered for up to 2 years. If they do not resume ivosidenib they will perform end of trial visit (and if this is not possible the pre-transplant visit will be considered as en of trial visit).

Conditions

• Acute Myeloid Leukemia With Gene Mutations

Interventions

Type	Name	Description
DRUG	Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET	Oral Decitabine (Decitabine/Cedazuridine 35 Mg-100 Mg) will be administerd on Days 1-5 of each treatment cycle
DRUG	Ivosidenib Oral Tablet	Ivosidenib 500 mg/orally on Days 1-28 of each treatment cycle
DRUG	Hydroxyurea	0.5-6 gram/day orally during the screening period and the two first treatment cycles if hyperleukocytosis at diagnosis
DRUG	Cytarabine	Maximum 1 gram/sqm/day during the screening period and the two first treatment cycles if hyperleukocytosis at diagnosis
PROCEDURE	Allogeneic stem cell transplantation	Only for those participants achieving CR/CRi

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

15 sites across 1 country: Spain