Recruiting NCT06001788
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ziftomenib, Fludarabine, Idarubicin, Cytarabine.
- Who it may be relevant to
- Registry conditions: AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Rate of dose limiting toxicities (DLTs) per dose level [Time frame: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)]
- Descriptive statistics of adverse events [Time frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first]
Secondary outcome measures (12)
- Complete remission (CR) rate for cohorts A-1, A-2, B-1, and B-2 [Time frame: Up to 12 months following discontinuation of treatment]
- Complete remission (CR) / Complete remission with partial hematologic recovery (CRh) rate for cohort A-3 [Time frame: Up to 12 months following discontinuation of treatment]
- Composite complete remission (CRc) rate [Time frame: Up to 12 months following discontinuation of treatment]
- Morphologic leukemia-free state (MLFS) rate [Time frame: Up to 12 months following discontinuation of treatment]
- OS [Time frame: Up to 12 months following discontinuation of treatment]
- 6-month OS [Time frame: Up to 6 months following discontinuation of treatment]
- Median EFS [Time frame: Up to 12 months following discontinuation of treatment]
- 6-month EFS [Time frame: Up to 6 months following discontinuation of treatment]
- DOR [Time frame: Up to 12 months following discontinuation of treatment]
- MRD assessment [Time frame: Up to 12 months following discontinuation of treatment]
- HSCT [Time frame: Up to 12 months following discontinuation of treatment]
- Transfusion independence [Time frame: Up to 12 months following discontinuation of treatment]
Eligibility criteria
Inclusion criteria
- Has been diagnosed with relapsed/refractory AML.
- Has a documented NPM1 mutation or KMT2A rearrangement.
- Has a documented FLT3 mutation (cA-3 only).
- Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
- Has adequate hepatic and renal function as defined per protocol.
- Has an ejection fraction above a protocol defined limit.
- Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
- Has agreed to use contraception as defined per protocol.
Exclusion criteria
- Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
- Has clinically active central nervous system leukemia.
- Has an active and uncontrolled infection.
- Has a mean corrected QT interval (QTcF) > 480ms.
- Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
- 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.
- Has had major surgery within 4 weeks prior to the first dose of study intervention.
- Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
- Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
- Participant is pregnant or lactating.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 38 centers
- Banner MD Anderson Cancer Center — Gilbert
- USC Norris Comprehensive Cancer Center — Los Angeles
- UCLA Health - Bowyer Oncology Center — Los Angeles
- UC Irvine Health Chao Family Comprehensive Cancer Center — Orange
- University of California San Francisco — San Francisco
- Colorado Blood Cancer Institute — Denver
- Smilow Cancer Hospital at Yale New Haven — New Haven
- Emory Healthcare - The Emory Clinic — Atlanta
- … and 30 more centers
Spain · 4 centers
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Universitario Central de Asturias — Oviedo
- Hospital Universitario Virgen del Rocío — Seville
- Hospital Universitari y Politecnic La Fe — Valencia
Italy · 3 centers
- IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola — Bologna
- Ospedale Santa Maria delle Croci — Ravenna
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT06001788 · KO-MEN-008