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
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.
Description
PRIMARY OBJECTIVE: \- To assess the clinical activity of canakinumab in patients with low or intermediate-1 myelodysplastic syndrome (MDS) or CCUS. SECONDARY OBJECTIVES: * To assess the safety profile of canakinumab in patients with low or intermediate-1 risk by - IPSS or IPSS-R score ≤3.5 MDS, CCUS * To assess the rate of transfusion independence (TI) * To assess duration of response EXPLORATORY OBJECTIVE: \- To assess pharmacodynamic (PD) parameters of canakinumab OUTLINE: Patients receive canakinumab subcutaneously (SC) on day 1. Cycles repeat every 28 days in the absence of disease…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 * Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant * Bone marrow aspirate excluding hematological malignancy and MDS…
Interventions
- BiologicalCanakinumab
Given SC
Location
- M D Anderson Cancer CenterHouston, Texas