OncoMatch/Clinical Trials/NCT04239157
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
Is NCT04239157 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Canakinumab for chronic myelomonocytic leukemia.
Treatment: Canakinumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Disease stage
Required: Stage LOW OR INTERMEDIATE-1 RISK BY IPSS OR IPSS-R WITH A SCORE OF ≤ 3.5
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: erythropoiesis-stimulating agent (ESA)
Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs)
Must have received: hypomethylating agent (azacitidine, decitabine, SGI-110, ASTX727, CC-486)
Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs). These could include azacitidine, decitabine, SGI-110, ASTX727, or CC-486. Patients will need to have received at least 4 cycles of HMA. Participants with relapse or progression after any number of cycles of HMA by IWG 2006 criteria will also be candidates.
Must have received: immunomodulatory drug (Lenalidomide)
Participants with evidence of del 5q alteration also are required to have been treated with Lenalidomide
Cannot have received: IL-1/IL-1r inhibitor
Prior treatment with IL-1/IL-1r inhibitors
Lab requirements
Blood counts
Absolute neutrophil count (ANC) <0.5x10^9 k/ul excluded; cytopenia required for CCUS cohort: ANC <1.8 or hgb <12 in females and <13 in males or a platelet count of <150
Kidney function
Serum creatinine clearance >30mL/min and no end/stage renal disease (using Cockcroft-Gault)
Liver function
total bilirubin ≤3 x ULN, AST or ALT ≤ 3xULN
Adequate hepatic function with total bilirubin ≤3 x ULN, AST or ALT ≤ 3xULN. Serum creatinine clearance >30mL/min and no end/stage renal disease (using Cockcroft-Gault). Absolute neutrophil count (ANC) <0.5x109 k/ul; colony-stimulating factors can be administered prior to study drug initiation. Presence of a cytopenia for >30 days. Cytopenia will be defined using accepted CHRS (Clonal Hematopoiesis Risk Score) criteria (Weeks et al, NEJM Evidence in press): ANC <1.8 or hgb <12 in females and <13 in males or a platelet count of <150.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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