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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

NCT04239157 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Canakinumab

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Guillermo Garcia-Manero · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239157 on ClinicalTrials.gov