CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 76 target
Drug / intervention
Canakinumabbiological
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age ≥18 years
  • ✓MDS diagnosis WHO 2016, low or intermediate-1 risk IPSS/IPSS-R ≤3.5 (Cohorts 1-3)
  • ✓CCUS diagnosis with somatic pathogenic variant, VAF ≥2%, no MDS morphology, cytopenia >30 days (Cohort 4)
  • ✓Cohort 1: Prior failure of ESAs or HMAs (≥4 cycles), or relapse/progression by IWG 2006, or del 5q treated with Lenalidomide
Key exclusion· 10
  • ✕Active infection not adequately responding to antibiotics
  • ✕Prior treatment with IL-1/IL-1r inhibitors
  • ✕ANC <0.5×10⁹ k/µL (CSF allowed prior to study drug)
  • ✕Pregnant or lactating females

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04239157
NCT04239157Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Jan 23, 2020·Updated May 20, 2026

In Brief

A Phase 2 clinical trial evaluating Canakinumab for Chronic Myelomonocytic Leukemia and 5 related conditions. Currently recruiting, targeting 76 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Novartis

Timeline

Phase 2Recruiting
20202021202220232024202520262027
First PostedJan 23, 2020
Enrollment StartAug 25, 2020
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 6.4 years agoPrimary completion in 6 months

Interventions

Canakinumabbiological

Given SC