NCT05907057 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Servier Affaires Médicales |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 245 participants |
| Start Date | 2023-06-14 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 245 participants in total. It began in 2023-06-14 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05907057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05907057 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 245 participants.
Is NCT05907057 currently recruiting?
Yes, NCT05907057 is actively recruiting participants. Contact the research team at scientificinformation@servier.com for enrollment information.
Where is the NCT05907057 trial being conducted?
This trial is being conducted at Vienna, Austria, Wels, Austria, Marseille, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT05907057 clinical trial?
NCT05907057 is sponsored by Servier Affaires Médicales. The trial plans to enroll 245 participants.
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