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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Conditions

• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndrome
• Recurrent Chronic Myelomonocytic Leukemia
• Recurrent Myelodysplastic Syndrome
• Refractory Chronic Myelomonocytic Leukemia
• Refractory Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Canakinumab	Given SC

Timeline

• Start date: 2020-08-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-01-23
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study