Phase II Study of Canakinumab for Patients with Low or Intermediate-Risk Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04239157

Provider View

This study is testing how well the drug canakinumab works in treating patients with low or intermediate-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). Canakinumab is a type of medication that may help stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

The purpose of this phase II trial is to see if canakinumab, a monoclonal antibody, is effective in treating patients with low or intermediate-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). Canakinumab may help by interfering with the growth and spread of cancer cells.

Description

Primary Objective:

  • To evaluate how well canakinumab works in patients with low or intermediate-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML).

Secondary Objectives:

  • To assess the safety of canakinumab in patients with low or intermediate-risk MDS or CMML.
  • To determine if patients can become independent of blood transfusions.
  • To measure how long the treatment response lasts.

Exploratory Objective:

  • To study how canakinumab affects the body.

Treatment Plan:

Patients will receive canakinumab as an injection under the skin on the first day of each 28-day cycle. This will continue as long as the disease does not progress and the patient does not experience unacceptable side effects.

After finishing the study treatment, patients will have follow-up visits 30 days later and then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, as MDS and CMML are rare in children.
  • Diagnosed with low or intermediate-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) based on specific medical criteria.
  • For certain groups, must have a specific genetic change related to blood cancers without visible signs of MDS.
  • Must have low blood cell counts for more than 30 days.
  • For some groups, must not have responded to previous treatments with certain medications.
  • Must have low hemoglobin levels with symptoms or need for blood transfusions.
  • Must agree to participate and understand the study, providing informed consent.
  • Must have adequate liver and kidney function based on specific blood tests.
  • Must have a performance status score of 2 or less, indicating ability to carry out light work.

Exclusion Criteria

  • Have an active infection not responding to treatment.
  • Have been treated with IL-1/IL-1r inhibitors before.
  • Have very low neutrophil counts.
  • Are pregnant or breastfeeding.
  • Are not willing to use effective birth control methods if of reproductive potential.
  • Have had another active cancer within the past 2 years, except for certain skin cancers or cervical cancer.
  • Are taking other investigational drugs or treatments within 14 days of starting the study.
  • Have a known HIV infection.
  • Require systemic steroids or other immunosuppressive drugs.

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