Actively Recruiting
Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Led by M.D. Anderson Cancer Center · Updated on 2026-01-05
66
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
I
Incyte, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
* To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML. * To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.
CONDITIONS
Official Title
Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of myelofibrosis by WHO or ICC criteria with prior therapy or suboptimal response to JAK inhibitor (for phase 1 and 2 cohorts)
- Diagnosis of CMML refractory to hydroxyurea or hypomethylating agents, or intolerant to these treatments
- ECOG performance status 0 to 2
- Adequate liver function with bilirubin and liver enzymes within 3 times upper limit of normal unless disease related
- Creatinine clearance greater than 30 mL/min without end-stage renal disease
- Prior hydroxyurea or hematopoietic growth factors allowed before therapy start
- Signed informed consent provided
- Patients with prior or concurrent malignancy that does not interfere with study assessments are eligible
- Cardiac function class 2B or better by New York Heart Association Functional Classification
- Women of child-bearing potential agree to use adequate contraception during study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving treatment for another active malignancy except certain skin, cervical, breast, or prostate cancers
- Receiving other investigational agents or prior CSF1-R inhibitor therapy
- Active uncontrolled infections (bacterial, fungal, parasitic, viral)
- Evidence of active or latent tuberculosis without adequate treatment
- Known malabsorption or conditions impairing medication absorption
- History of acute or chronic pancreatitis
- Active symptomatic myositis
- Platelet count below 50 x 10^9/L prior to enrollment for combination therapy cohorts unless treatment related
- Pregnant or breastfeeding women
- Not willing to follow contraception requirements
- Positive pregnancy test at screening for women of reproductive potential
- Concurrent treatments with chemotherapy, radiotherapy, immunotherapy within 7 days before starting study therapy
- History of chronic hepatitis B or C
- History of HIV infection
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction below 50%
- Recent myocardial infarction, thromboembolic disease, unstable angina, or severe arrhythmias
- Psychiatric or social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Naveen Pemmaraju, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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