🏛️ Verified NIH Record • Updated 2026-07-14

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) (NCT07128381)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

* 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (18 items).

Location: The University of Texas M. D. Anderson Cancer Center — Houston, Texas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients who are currently receiving treatment for a malignancy (not including basal cell carcinoma, nonmelanoma skin cancer, cervical carcinoma in situ, early stage breast cancer or localized prostate cancer treated with hormone therapy). Patients with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.
  • Patients who are receiving any other investigational agents or with prior CSF1-R inhibitor therapy.
  • Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.
  • Patients with evidence of active or latent tuberculosis. Prior to enrollment, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed.
  • Patients who have a known malabsorption syndrome or other condition that may impair absorption of study medication (e.g., gastrectomy).
  • History of acute or chronic pancreatitis.
  • Active symptomatic myositis.
  • Platelet count \<50x109/L prior to enrollment and treatment initiation (for ruxolitinib combination cohorts only) except if related to either treatment for MF or CMML or treatment with cytotoxic therapy for any other reason.
  • Pregnant women are excluded from this study because axatilimab and ruxolitinib are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.
  • Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \[birth control pills\], contraceptive injections, intrauterine devices \[IUD\], doublebarrier method \[spermicidal jelly or foam with condoms or diaphragm\], contraceptive patch, or surgical sterilization) throughout the study.
  • Female patients with reproductive potential who do not have a negative urine or blood betahuman chorionic gonadotropin (beta HCG) pregnancy test at screening.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • The University of Texas M. D. Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 792-4956

Email: npemmaraju@mdanderson.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗