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New treatment option for Targeted Therapy
Official title Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
ClinicalTrials.gov ID: NCT07032727
What this study is testing
What is Olutasidenib?
Olutasidenib is an investigational medicine, being studied as a potential treatment for targeted therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn about the safety and tolerability of study drug combinations in patients with relapsed/refractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Participants with a diagnosis of relapsed and/or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component) OR...
- Participants must have a documented IDH1 mutation.
- Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD...
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
You likely can't join if
- Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).
- Participants with translocation t(15;17) or acute promyelocytic leukemia (French-American British (FAB) class M3-AML).
- Participants with any concurrent uncontrolled clinically significant medical condition, including life threatening infection, which could place the...
- Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.
- Participants with a New York Heart Association (NYHA) Functional Classification of III or IV.
- Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant (Participants without active GVHD on phototherapy for...
See the full eligibility criteria
- Age ≥ 18 years.
- Participants with a diagnosis of relapsed and/or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component) OR high-risk MDS, MPN, or MDS/MPN (defined as ≥10% blasts on peripheral flow...
- Participants must have a documented IDH1 mutation.
- Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Adequate renal function with estimated GFR ≥ 30 by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- Adequate hepatic function, defined as direct bilirubin ≤ 2x upper limit of normal (ULN) and AST and ALT ≤ 3x ULN unless the increase is due to Gilbert's disease or leukemic involvement, in which case direct bilirubin...
- The interval from prior treatment to time of initiation will be at least 14 days OR five half-lives for both cytotoxic and non-cytotoxic (e.g. immunotherapy agent(s)). Oral hydroxyurea and/or cytarabine (up to 2g/m2) is...
- Ability to understand and the willingness to sign an informed consent document.
- Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).
- Participants with translocation t(15;17) or acute promyelocytic leukemia (French-American British (FAB) class M3-AML).
- Participants with any concurrent uncontrolled clinically significant medical condition, including life threatening infection, which could place the patient at unacceptable risk of study treatment.
- Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.
- Participants with a New York Heart Association (NYHA) Functional Classification of III or IV.
- Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant (Participants without active GVHD on phototherapy for chronic skin GVHD are permitted after discussion with the PI)...
- Participants with active, uncontrolled CNS leukemia.
- Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection. For participants with evidence of chronic HBV or HIV infection, the HBV or HIV viral load must be undetectable...
- Participant has white blood cell count \>25 x 109/L (Note: Hydroxyurea and cytarabine are permitted to mean this criterion).
- The effects of the study drug on the developing human fetus or transmission through breast feeding are unknown. Therefore, nursing women and women with a positive urine pregnancy test and excluded. Additionally, women...
- History of an allergic reaction to venetoclax, gilteritinib, ruxolitinib, cladribine, or cytarabine.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.