Trial Title:
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT06001788
Condition:
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
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Hematologic Neoplasms
Neoplasms by Histologic Type
Cytarabine
Fludarabine
Idarubicin
Lenograstim
Gilteritinib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ziftomenib
Description:
Oral administration
Arm group label:
Phase 1a
Arm group label:
Phase 1b
Other name:
KO-539
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Intravenous infusion
Arm group label:
Phase 1a
Arm group label:
Phase 1b
Intervention type:
Drug
Intervention name:
Idarubicin
Description:
Intravenous infusion
Arm group label:
Phase 1a
Arm group label:
Phase 1b
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Intravenous Infusion
Arm group label:
Phase 1a
Arm group label:
Phase 1b
Intervention type:
Drug
Intervention name:
Gilteritinib
Description:
Oral administration
Arm group label:
Phase 1a
Arm group label:
Phase 1b
Other name:
Xospata
Intervention type:
Biological
Intervention name:
Granulocyte colony-stimulating factor
Description:
Subcutaneous injection
Arm group label:
Phase 1a
Arm group label:
Phase 1b
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Has been diagnosed with relapsed/refractory AML.
- Has a documented NPM1 mutation or KMT2A rearrangement.
- Has a documented FLT3 mutation (cohort A-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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Ulrickson, MD
Facility:
Name:
UCLA Health - Bowyer Oncology Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bruck Habtemariam
Email:
bhabtemariam@mednet.ucla.edu
Facility:
Name:
UCI Health Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Phone:
949-824-8170
Email:
irb@uci.edu
Facility:
Name:
Smilow Cancer Hospital at Yale New Haven
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Farah Fasihuddin
Email:
farah.fasihuddin@yale.edu
Facility:
Name:
The University of Kansas
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
KUCC Navigation Team
Phone:
913-588-3671
Email:
kucc_navigation@kumc.edu
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cathy Galasso
Email:
galassoc@karmanos.org
Facility:
Name:
Henry Ford Cancer Institute
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristyn Dailey
Email:
KDailey6@hfhs.org
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Michael Haddadin, MBBS
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aaron Goldberg, MD, PhD
Phone:
646-608-3752
Email:
goldbera@mskcc.org
Facility:
Name:
Stony Brook Cancer Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zita Makselyte
Email:
zita.makselyte@stonybrookmedicine.edu
Facility:
Name:
Atrium Health Levine Cancer Center
Address:
City:
Charlotte
Zip:
60201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chari Granger
Email:
Chari.Granger@atriumhealth.org
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cynthia J Lowery
Email:
Cynthia-Lowery@ouhsc.edu
Facility:
Name:
Prisma Health
Address:
City:
Greenville
Zip:
29615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Johnson
Phone:
864-455-3735
Email:
lisa.johnson@prismahealth.org
Contact backup:
Last name:
Fiona Davidson
Phone:
864-455-3737
Email:
fiona.davidson@prismahealth.org
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Pike
Phone:
713-745-6756
Email:
apike@mdanderson.org
Contact backup:
Last name:
Ghayas C Issa, MD
Phone:
713-745-6798
Email:
gcissa@mdanderson.org
Start date:
February 22, 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Kura Oncology, Inc.
Agency class:
Industry
Source:
Kura Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001788
