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

ConditionsChronic Myelomonocytic Leukemia Myelodysplastic Syndrome Recurrent Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic Syndrome Refractory Chronic Myelomonocytic Leukemia Refractory Myelodysplastic Syndrome

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

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.

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

Disqualifiers

Active infection not adequately responding to appropriate antibiotics.

Prior treatment with IL-1/IL-1r inhibitors

Absolute neutrophil count (ANC) <0.5x109 k/ul; colony-stimulating factors can be administered prior to study drug initiation.

Female participants who are pregnant or lactating.

Trial design

Treatments tested in this trial

Canakinumab

Treatment groups

76 Participants

are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Novartis

Collaborator

Source ClinicalTrials.gov