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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07032727
Phase
PHASE2
Status
Recruiting
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Conditions

  • IDH1-Mutated Malignancies
  • Mutations
  • Targeted Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 12, 2025
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1A Safety Lead-In/Expansion:
    Treatment with Olutasidenib + Cladribine + Cytarabine
  • Experimental: Arm 1B Expansion
    Treatment with Olutasidenib + Cladribine + Cytarabine + Venetoclax
  • Experimental: Arm 2A Safety Lead-In/Expansion
    Treatment with Olutasidenib + Gilteritnib
  • Experimental: Arm 2B Expansion
    Treatment with Olutasidenib + Gilteritnib + Venetoclax
  • Experimental: Arm 3A Safety Lead-In/Expansion:
    Treatment with Olutasidenib + Ruxolitinib

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Courtney DiNardo, MD
[email protected]
713-794-1141
Courtney DiNardo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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