Trials / Recruiting
RecruitingNCT06001788
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 171 (estimated)
- Sponsor
- Kura Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Conditions
- AML
- AML With Mutated NPM1
- Hematologic Malignancy
- KMT2Ar
- NPM1 Mutation
- MLL Rearrangement
- Leukemia
- Acute Myeloid Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Acute Leukemia
- Neoplasms by Histologic Type
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ziftomenib | Oral administration |
| DRUG | Fludarabine | Intravenous infusion |
| DRUG | Idarubicin | Intravenous infusion |
| DRUG | Cytarabine | Intravenous Infusion |
| DRUG | Gilteritinib | Oral administration |
| BIOLOGICAL | Granulocyte colony-stimulating factor | Subcutaneous injection |
Timeline
- Start date
- 2024-02-22
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
- First posted
- 2023-08-21
- Last updated
- 2026-04-14
Locations
45 sites across 3 countries: United States, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06001788. Inclusion in this directory is not an endorsement.