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)
M.D. Anderson Cancer Center
Summary
* 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.
Description
Primary Objectives: * Phase 1 dose escalation: to determine safety, tolerability and Maximum Tolerated Dose (MTD) and efficacy of axatilimab alone and in combination with ruxolitinib for patients with MF and CMML * Phase 2 dose expansion: to determine the overall response rate (ORR) of axatilimab and ruxolitinib in patients with MF and CMML. * Incidence of AEs, MTD and changes in clinical laboratory values. * Measures of efficacy in CMML: overall response rate (ORR) defined as sum of CR + complete cytogenetic remission + partial remission + marrow response + clinical benefit according to the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age .18 years as MF and CMML are very rare diseases in the pediatric population. * Diagnosis of MF by WHO or ICC and: 1. Phase 1 dose escalation (Cohort A and B): at least 1 prior therapy for MF or with suboptimal response after at least 3 months of therapy with a JAK inhibitor. 2. Phase 2 dose expansion: i. Relapsed cohort (Cohort C): Patients with at least 1 prior MF therapy. or ii. JAKi-naive cohort (Cohort D): patients with newly diagnosed and treatment naive MF with intermediate .1 risk by DIPSS-plus (Appendix 2) * Diagnosis of CMML refractory to treatment w…
Interventions
- DrugAxatilimab (SNDX-6352)
Taken orally
- DrugRuxolitinib
Taken orally
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas