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

Part of paid clinical trials in Miami, Florida.

Sponsor
Uma Borate
Study ID
NCT05641831
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Clonal Cytopenia of Undetermined Significance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo peripheral blood collection
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Canakinumab — DRUG
    Given SC
  • Chest Radiography — PROCEDURE
    Undergo chest x-ray
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Placebo Administration — DRUG
    Given SC
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

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).

Key Dates

Start date
Feb 6, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM I (canakinumab)
    Patients receive canakinumab SC on study. All patients also undergo ECHO and chest x-ray during screening, collection of blood samples during screening and follow up, and bone marrow biopsy and aspiration throughout the trial.
  • Placebo Comparator: ARM II (placebo)
    Patients receive placebo SC on study. All patients also undergo ECHO and chest x-ray during screening, collection of blood samples during screening and follow up, and bone marrow biopsy and aspiration throughout the trial.

Primary Outcome Measure

Time to overt myeloid malignancy [ Time Frame: From the date of randomization until the first date of overt myeloid malignancy diagnosis, assessed up to 6 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Namrata Chandhok, MD
[email protected]
305-243-8238
Namrata S Chandhok, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Tamanna Haque, MD
[email protected]
646-608-4166
Tamanna Haque, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10021
Pinkal Desai, M.D.
646-962-2700
Pinkal Desai, M.D. (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Uma M. Borate, MD, MS
[email protected]
614-293-3316
Uma M. Borate, MD, MS (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Vanderbilt University Medical Center
[email protected]
1-800-811-8480
Ashwin Kishtagari, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical Center at DallasDallasTexas75235
Donglan Xia, PhD, BSN
[email protected]
214-645-9656
Silviya Meletath, MD, MBS
[email protected]
909-560-9597
Yazan Madanat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLMemorial Sloan Kettering Cancer Center· New York, NYWeill Cornell Medical College· New York, NYOhio State University Comprehensive Cancer Center· Columbus, OHVanderbilt University Medical Center· Nashville, TNUT Southwestern Medical Center at Dallas· Dallas, TX

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