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A Phase 1b/2 Study Evaluating the Safety and Efficacy of Canakinumab With Darbepoetin Alfa in Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Who Have Failed Erythropoietin Stimulating Agents (ESA)
This study is a multi-institution, open-label, Phase 1b/2 clinical trial evaluating the toxicity and efficacy of canakinumab in combination with darbepoetin alfa in patients with lower-risk MDS who have failed prior treatment with an Erythropoietin Stimulating Agent (ESA)
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 13 |
| Start date | 2021-03-30 |
| Completion | 2026-07 |
Conditions
- Myelodysplastic Syndromes
Interventions
- Canakinumab Injection
- Darbepoetin Alfa
Primary outcomes
- Phase 1b: Maximum Tolerated Dose (MTD) — up to 28 days per cohort
Maximum tolerated Dose will be determined by testing increasing doses of canakinumab along with a fixed dose of darbepoetin alfa. Patients will be followed for at least 1 cycle before the safety of each cohort can be fully assessed and decisions made for dose escalation in the next cohort. The MTD is defined as the dose level below which DLT is manifested in ≥33% of the patients or at dose level 2 if DLT is manifested in \<33% of the patients (with at 6 patients treated at the MTD). - Phase 2: Rate of Hematologic Improvement-Erythroid (HI-E) response — 8 - 12 weeks from baseline
To determine the rate of hematologic improvement-erythroid (HI-E) response, defined as red blood cell transfusion independence (RBC-TI) of at least 8 weeks in transfusion dependent patients or a mean Hgb increase of \>/=1.5g/dL above baseline sustained for at least 8 weeks in non-transfusion dependent patients.
Countries
United States