NCT05641831

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

Recruiting now Phase 2 Last updated 2 January 2026

What this trial tests

Phase 2 trial testing Biospecimen Collection in Clonal Cytopenia of Undetermined Significance in 110 participants. Currently enrolling.

Timeline

6 February 2023

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Uma Borate
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	6 February 2023
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	6 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Bone Marrow Aspiration and Biopsy
• Canakinumab (CANAKINUMAB) — full drug profile →
• Chest Radiography
• Echocardiography
• Placebo Administration — full drug profile →
• Quality-of-Life Assessment

Conditions studied

• Clonal Cytopenia of Undetermined Significance — all drugs for Clonal Cytopenia of Undetermined Significance →

Sponsor

Uma Borate

Who can join

18 and older, any sex, with Clonal Cytopenia of Undetermined Significance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Involvement of inflammasomes in tumor microenvironment and tumor therapies.
   Zhang Z, Li X, Wang Y, Wei Y, et al · · 2023 · cited 55× · PMID 36932407 · DOI 10.1186/s13045-023-01407-7
2. Clonal Hematopoiesis: Updates and Implications at the Solid Tumor-Immune Interface.
   Buttigieg MM, Rauh MJ. · · 2023 · cited 22× · PMID 37343201 · DOI 10.1200/po.23.00132
3. Clonal hematopoiesis and hematological malignancy.
   Dunn WG, McLoughlin MA, Vassiliou GS. · · 2024 · cited 19× · PMID 39352393 · DOI 10.1172/jci180065
4. Pathogenesis and inflammaging in myelodysplastic syndrome.
   Villaume MT, Savona MR. · · 2025 · cited 15× · PMID 39445405 · DOI 10.3324/haematol.2023.284944
5. A blueprint for pursuing therapeutic interventions and early phase clinical trials in clonal haematopoiesis.
   Haque T, Shastri A, Desai P, Xie Z, et al · · 2025 · cited 9× · PMID 39653653 · DOI 10.1111/bjh.19925
6. Prevention and treatment of transformation of myeloproliferative neoplasms to acute myeloid leukemia.
   Patel AA, Rampal RK. · · 2025 · cited 9× · PMID 39445417 · DOI 10.3324/haematol.2023.283950
7. CHIP: a clonal odyssey of the bone marrow niche.
   Schleicher WE, Hoag B, De Dominici M, DeGregori J, et al · · 2024 · cited 7× · PMID 39087468 · DOI 10.1172/jci180068
8. Genetic and environmental risks for clonal hematopoiesis and cancer.
   Franco S, Godley LA. · · 2025 · cited 5× · PMID 39626264 · DOI 10.1084/jem.20230931