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

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.

Trial Details

NCT ID

NCT04239157

Phase

PHASE2

Sponsor

M.D. Anderson Cancer Center

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Canakinumab

Locations (sample)

Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.
Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.
Cohort 4: Diagnosis of CCUS defined as:
Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia

For full eligibility, visit ClinicalTrials.gov.

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