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Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study

ConditionClonal Cytopenia of Undetermined Significance
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUma Borate

About this trial

This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with age >= 18 with high-risk CCUS

Hemoglobin < 11 g/dL

Absolute Neutrophil Count < 1800/microL and > 500/microL

Platelet Count < 150,000/microL and > 50,000/microL

Disqualifiers

Concurrent malignancy requiring active systemic therapy

Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime

History of Hypersensitivity to canakinumab or drug of a similar class

Active infection requiring prompt evaluation and treatment or history of recurrent infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo peripheral blood collection

  • Bone Marrow Aspiration and Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Canakinumab

    Drug

    Given SC

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Placebo Administration

    Drug

    Given SC

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: ARM I (canakinumab)Experimental treatment 6 interventions
Group B: ARM II (placebo)Placebo comparator 6 interventions

Trial outcomes

Primary outcomes

1

Time to overt myeloid malignancy

Will be estimated with the non-parametric Kaplan-Meier method to compute the median time as well as the percentage of study participants with a diagnosed hematologic malignancy of myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML)/ acute myeloid leukemia (AML) at landmark time points (e.g., 1-year, 2-years) with corresponding 95% confidence intervals. Since this method will censor patients who die without having developed MDS/MPN/CMML/AML, we will also compute the cumulative incidence of overt myeloid malignancy that accounts for the competing risk of death in the absence of a hematologic malignancy. All randomized patients will be included in the primary endpoint analysis in the arm to which they were randomized (ie, intent-to-treat population).

Time frame
From the date of randomization until the first date of overt myeloid malignancy diagnosis, assessed up to 6 years

Secondary outcomes

1

Hematological overall response rate

Number of patients that achieve response divided by the number or randomized patients. Will be summarized using the method of Kaplan-Meier but also using the cumulative incidence function which would treat death in the absence of documented relapse as a completing risk.

Time frame
6 month assessment
2

Complete hematological response rate

Number of patient that achieve complete response divided by the number of randomized patients. Will be summarized using the method of Kaplan-Meier but also using the cumulative incidence function which would treat death in the absence of documented relapse as a completing risk.

Time frame
6 month assessment
3

Duration of hematological response

Will be summarized using the method of Kaplan-Meier but also using the cumulative incidence function which would treat death in the absence of documented relapse as a completing risk.

Time frame
From the date of first documented hematological response until the date of documented diagnosis of MDS, MPN, CMML, or AML, assessed up to 6 years
4

Overall survival

Will be estimated using the method of Kaplan-Meier and estimates at landmark time points (e.g., 1-year, 2-years) will be provided with corresponding 95% confidence intervals.

Time frame
From the date of registration until the date of death from any cause, assessed up to 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uma Borate

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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