Actively Recruiting
A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
76
Participants Needed
1
Research Sites
331 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
CONDITIONS
Official Title
A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of MDS according to WHO 2016 classification with low or intermediate-1 risk by IPSS or IPSS-R scoring 3.5 or less
- Diagnosis of CCUS defined by presence of somatic pathogenic variant associated with blood cancer without morphological myelodysplasia, variant allele fraction ≥2%, bone marrow aspirate excluding hematological malignancy and MDS, and cytopenia lasting more than 30 days
- For cohort 1, prior treatment with erythropoiesis-stimulating agents or hypomethylating agents including at least 4 cycles of HMA, or relapse/progression after any number of HMA cycles
- For cohort 1, hemoglobin less than 10 g/dL with symptomatic anemia or transfusion dependency needing prior transfusion within 8 weeks for hemoglobin below 8 g/dL
- For cohort 2, transfusion dependency defined as prior transfusion of at least 2 units PRBC for hemoglobin less than 8 g/dL or symptomatic anemia (hemoglobin <10 g/dL), or any platelet transfusion within 8 weeks
- Signed informed consent
- Adequate liver function with total bilirubin ≤3 times upper limit normal, AST or ALT ≤3 times upper limit normal
- Serum creatinine clearance greater than 30 mL/min and no end-stage renal disease
- ECOG performance status 0 to 2
You will not qualify if you...
- Active infection not responding to appropriate antibiotics
- Prior treatment with IL-1 or IL-1 receptor inhibitors
- Absolute neutrophil count less than 0.5 x 10^9 /L (colony-stimulating factors allowed before study drug)
- Pregnancy or lactation
- Participants with reproductive potential unwilling to comply with contraception requirements during the study
- Female participants with reproductive potential without a negative pregnancy test at screening
- History of active malignancy within past 2 years except adequately treated in situ cervical carcinoma, basal cell carcinoma, localized squamous cell carcinoma of skin, or other malignancy with life expectancy over 2 years
- Receiving other investigational agents, chemotherapy, radiotherapy, or immunotherapy within 14 days before study treatment
- Known HIV infection
- Use of systemic steroids, methotrexate, or other immunosuppressive drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Guillermo Garcia-Manero
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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