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

First listed
Jun 24, 2025
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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