OncoMatch/Clinical Trials/NCT06001788
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT06001788 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for aml.
Treatment: Ziftomenib · Fludarabine · Idarubicin · Cytarabine · Gilteritinib · Granulocyte colony-stimulating factor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Chronic Myeloid 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
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 →Frequently asked questions
Is NCT06001788 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any anticancer therapy, hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require FLT3?
Yes, FLT3 mutation is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify