Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

ConditionsTargeted Therapy IDH1-Mutated Malignancies Mutations

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 cytometry or bone marrow biopsy).

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Olutasidenib
Drug
Given by po
Cladribine (CLAD)
Drug
Given by IV
Venetoclax
Drug
Given by po
Gilteritinib
Drug
Given by po
Ruxolitinib
Drug
Given by po
Cytarabine
Drug
Given SQ

Treatment groups

68 Participants

are divided into 5 treatment groups

Group A: Arm 1A Safety Lead-In/Expansion:Experimental treatment 3 interventions

Group B: Arm 1B ExpansionExperimental treatment 4 interventions

Group C: Arm 2A Safety Lead-In/ExpansionExperimental treatment 2 interventions

Group D: Arm 2B ExpansionExperimental treatment 3 interventions

Group E: Arm 3A Safety Lead-In/Expansion:Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Rigel Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

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