Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory A… (NCT04250051) | Clinical Trial Compass
TerminatedPhase 1
Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia
Stopped: Low accrual
United States2 participantsStarted 2020-12-21
Plain-language summary
This phase I trial studies the side effects and best dose of ivosidenib when given together with combination chemotherapy for the treatment of 1DH1 mutant acute myeloid leukemia that is newly diagnosed (previously untreated), has come back (relapsed), or does not respond to treatment (refractory). Ivosidenib may stop the growth of cancer cells by blocking the IDH1 mutation and some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and filgrastim, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib with combination chemotherapy may work better in treating patients with acute myeloid leukemia compared to chemotherapy alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have newly diagnosed previously untreated AML or relapsed/refractory primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms \[MPN\], or therapy-related) AML according to the WHO classification with ≥ 5% leukemic blasts in the bone marrow.
* Patients with relapsed/refractory primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms \[MPN\], or therapy-related) AML may have received prior therapies and there are no limits on number of therapies.
* Note: There is a requirement of 7 day washout from prior therapy or 5 half-lives, whichever is shorter.
* Patients with newly diagnosed or relapsed/refractory high-risk MDS or MDS/MPN (defined as ≥ 10% bone marrow blasts, or intermediate or high risk by International Prognostic Scoring System \[IPSS\], revised \[R\]-IPSS or dynamic \[D\]-IPSS) may also be eligible after discussion with the PI.
* Patient must have documentation of an IDH1 R132 mutation obtained prior to registration. IDH mutational status will be assessed locally.
* Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patients must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of ivosidenib in combination with FLAG (± IDA) chemotherapy
Timeframe: Up to day 42 of the first treatment cycle