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OncoMatch/Clinical Trials/NCT06001788

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Is NCT06001788 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for aml.

Phase 1RecruitingKura Oncology, Inc.NCT06001788Data as of May 2026

Treatment: Ziftomenib · Fludarabine · Idarubicin · Cytarabine · Gilteritinib · Granulocyte colony-stimulating factorThe 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: FLT3 mutation

Required: KMT2A (MLL) rearrangement

Required: NPM1 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Cannot have received: any anticancer therapy

Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention

Cannot have received: hematopoietic stem cell transplant

Exception: allowed if adequate recovery per protocol defined criteria

Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria

Lab requirements

Kidney function

adequate renal function as defined per protocol

Liver function

adequate hepatic function as defined per protocol

Cardiac function

ejection fraction above a protocol defined limit; mean corrected QT interval (QTcF) > 480ms [excluded]

Has adequate hepatic and renal function as defined per protocol. Has an ejection fraction above a protocol defined limit. Has a mean corrected QT interval (QTcF) > 480ms [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • USC Norris Comprehensive Cancer Center · Los Angeles, California
  • UCLA Health - Bowyer Oncology Center · Los Angeles, California
  • UC Irvine Health Chao Family Comprehensive Cancer Center · Orange, California
  • University of California San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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