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

NCT07507760 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia With Gene Mutations

Interventions

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

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Pau Montesinos · Hospital Universitari i Politèncic La Fe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507760 on ClinicalTrials.gov