RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 willing to sign a consent form prior to the first screening procedure.
- Has agreed to use contraception as defined per protocol.
Key Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Key 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.
Key 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.
Treatments Being Tested
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
Locations (20)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Health - Bowyer Oncology Center
Los Angeles, California, United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Simmons Cancer Institute
Springfield, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States