RecruitingPhase 2NCT04239157

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

76 participants

Start Date

Aug 25, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called canakinumab (which targets inflammation in the body) in patients with low-risk myelodysplastic syndrome (MDS) — a bone marrow disorder where the marrow doesn't produce enough healthy blood cells — or a related pre-cancerous blood condition called CCUS. The goal is to see if reducing inflammation can improve blood cell production. **You may be eligible if...** - You are 18 or older - You have a diagnosis of low or intermediate-risk MDS (per standard classification), OR - You have a condition called CCUS (clonal cytopenia of undetermined significance) with a confirmed genetic mutation and persistent low blood counts - For some groups: your MDS has not responded to prior treatments such as erythropoiesis-stimulating agents or hypomethylating agents - You have symptomatic anemia or need blood transfusions **You may NOT be eligible if...** - You have high-risk MDS or acute leukemia - You have active, serious infections - You are pregnant or breastfeeding - You have serious organ dysfunction - You have had a prior stem cell transplant (in some cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCanakinumab

Given SC


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04239157


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