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NCT04239157
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
Recruiting now
Phase 2
Last updated 13 April 2026
What this trial tests
Phase 2 trial testing Canakinumab in Chronic Myelomonocytic Leukemia in 76 participants. Currently enrolling.
Timeline
25 August 2020
Primary endpoint
31 December 2026
31 December 2026
31 December 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 25 August 2020 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Canakinumab (CANAKINUMAB) — full drug profile →
Conditions studied
- Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
- Recurrent Chronic Myelomonocytic Leukemia — all drugs for Recurrent Chronic Myelomonocytic Leukemia →
- Recurrent Myelodysplastic Syndrome — all drugs for Recurrent Myelodysplastic Syndrome →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Chronic Myelomonocytic Leukemia or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interleukins in cancer: from biology to therapy.
Briukhovetska D, Dörr J, Endres S, Libby P, et al · · 2021 · cited 587× · PMID 34083781 · DOI 10.1038/s41568-021-00363-z -
Roles of IL-1 in Cancer: From Tumor Progression to Resistance to Targeted Therapies.
Gelfo V, Romaniello D, Mazzeschi M, Sgarzi M, et al · · 2020 · cited 135× · PMID 32825489 · DOI 10.3390/ijms21176009 -
Current challenges and unmet medical needs in myelodysplastic syndromes.
Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. · · 2021 · cited 67× · PMID 34045662 · DOI 10.1038/s41375-021-01265-7 -
Targeting interleukin-1β and inflammation in lung cancer.
Zhang J, Veeramachaneni N. · · 2022 · cited 56× · PMID 35086565 · DOI 10.1186/s40364-021-00341-5 -
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 -
Therapeutic Strategies for Targeting IL-1 in Cancer.
Gottschlich A, Endres S, Kobold S. · · 2021 · cited 42× · PMID 33530653 · DOI 10.3390/cancers13030477 -
The Role of Inflammation in the Initiation and Progression of Myeloid Neoplasms.
Balandrán JC, Lasry A, Aifantis I. · · 2023 · cited 34× · PMID 37052531 · DOI 10.1158/2643-3230.bcd-22-0176 -
Therapeutic targeting of the inflammasome in myeloid malignancies.
Chakraborty S, Shapiro LC, de Oliveira S, Rivera-Pena B, et al · · 2021 · cited 29× · PMID 34521810 · DOI 10.1038/s41408-021-00547-8
Verify or expand the search:
- PubMed search for NCT04239157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Canakinumab
Trials testing the same drug.
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- NCT05984602 — A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclit · Phase 1 · active not recruiting
- NCT05401578 — Canakinumab for the Treatment of Postprandial Hypoglycemia · Phase 3 · recruiting
- NCT05641831 — Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPA · Phase 2 · recruiting
- NCT05535738 — Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation · Phase 2, PHASE3 · recruiting
Other recruiting trials for Chronic Myelomonocytic Leukemia
Currently open trials in the same condition.
- NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
- NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
- NCT07046078 — Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hem · Phase 2 · recruiting
- NCT06630221 — Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations · Phase 2 · recruiting
- NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04239157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04239157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing