Trial Title:
An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
NCT ID:
NCT05907057
Condition:
Acute Myeloid Leukemia (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Ivosidenib
Conditions: Keywords:
IDH1 Mutation AML
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ivosidenib 500mg Oral Tablet
Description:
Provided as tablets, taken orally as two 250mg tablets once daily.
Arm group label:
Open-Label Ivosidenib in combination with Azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Administered subcutaneously (SC) or intravenously (IV) at a dose of 75mg/m2/day for 7
days, either consecutively on Days 1-7 or discontinuously for Days 1-5 and 8-9 of each
cycle. The 7 days of administration will occur at the beginning of every 4 week-long
cycle.
Arm group label:
Open-Label Ivosidenib in combination with Azacitidine
Summary:
The purpose of this study is to learn more about the safety and efficacy of ivosidenib
taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are
presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive
[IDH1m]) and cannot receive treatment with intensive chemotherapy (IC).
Detailed description:
Participants who are eligible and enroll in the study will attend a study visit on the
first day of each 28-day cycle. Study visits will consist of a physical exam, blood work,
electrocardiogram (ECG) and other assessments. After treatment discontinuation
participants will be contacted every 12 weeks through the end of the study (currently
planned for 2026) to assess survival. The study drug, Ivosidenib, will be taken once
daily throughout the duration of participation in the study, and Azacitidine will only be
administered for 7 days at the beginning of each 28 day cycle. If at any point ivosidenib
is made available as a medical prescription at the patient's site, the patient will
switch to commercial product and will continue to be followed according to the protocol.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has untreated Acute Myeloid Leukemia (AML)
- Have a documented IDH1 R132 gene-mutated disease
- Have at least one of the following making yourself ineligible for intensive
chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance
Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be
incompatible with IC including but not limited to severe cardiac or pulmonary
disorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5
times the upper limit of normal
- Has adequate hepatic (liver) and renal (kidney) function
- Female participants of reproductive potential must have a negative blood pregnancy
test and must use effective contraception during treatment and for at least 6 months
following treatment
- Fertile male participants with female partners of reproductive potential must use
effective contraception during treatment and for at least 3 months following
treatment
Exclusion Criteria:
- Has received any prior treatment for AML, with the exception of hydroxyurea or
leukapheresis for white blood cell count control
- Has received prior treatment with an IDH1 inhibitor
- Is a woman who is pregnant or breastfeeding
- Has an active, uncontrolled, systemic fungal, bacterial, or viral infection
(including human immunodeficiency virus [HIV], active hepatitis B (HBV), or
hepatitis C virus [HCV]) without improvement despite appropriate antibiotics,
antiviral therapy, and/or other treatment
- Has had significant active cardiac disease within 6 months prior to the start of
study treatment, including Class III or IV congestive heart failure, myocardial
infarction (heart attack), unstable angina (chest pain), and/or stroke
- Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach
paralysis), or any other condition that limits the ingestion or gastrointestinal
absorption of orally administered drugs
- Has uncontrolled hypertension (high blood pressure)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AKH - Medizinische Universität Wien
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Completed
Facility:
Name:
Klinikum Wels-Grieskirchen GmbH
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Completed
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Facility:
Name:
CHU CAEN - Hôpital de la Côte de Nacre
Address:
City:
Caen
Zip:
14033
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Toulouse pt
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Rennes - Hopital Pontchaillou
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU Angers - Hôpital Hôtel Dieu
Address:
City:
Angers
Zip:
49100
Country:
France
Status:
Not yet recruiting
Facility:
Name:
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Ospedale Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Address:
City:
Perugia
Zip:
06135
Country:
Italy
Status:
Recruiting
Facility:
Name:
Meander Medisch Centrum
Address:
City:
Amersfoort
Zip:
3818 AZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Rijnstate
Address:
City:
Arnhem
Zip:
6815 AD
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Start date:
June 14, 2023
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Servier Affaires Médicales
Agency class:
Industry
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907057
