Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04798339
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • Canakinumab Injection — DRUG
    Participants will be treated at 1 of 2 dose levels of Canakinumab, beginning at 150 mg and increasing to 300 mg or the Maximum Tolerated Dose
  • Darbepoetin Alfa — DRUG
    Participants will receive Darbepoetin alfa subcutaneously at a dose of 300mg on days 1 and 15 of each cycle

Study Details

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)

Key Dates

Start date
Mar 30, 2021
Status verified
Oct 2025
Primary completion
May 26, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Dose Level 1
    Patients will be treated at dose level 1: Canakinumab 150 mg by subcutaneous injection on day 1 of each 28 day cycle. Darbepoetin alfa will be administered subcutaneously at a dose of 300mg on days 1 and 15 of each cycle.
  • Experimental: Phase 1b: Dose Level 2
    Patients will be treated at dose level 2: Canakinumab 300 mg by subcutaneous injection on day 1 of each 28 day cycle. Darbepoetin alfa will be administered subcutaneously at a dose of 300mg on days 1 and 15 of each cycle.
  • Experimental: Phase 2: Treatment at Maximum Tolerated Dose
    Patients will be treated with Darbepoetin alfa subcutaneously at a dose of 300 mg on days 1 and 15 of each cycle plus the maximum tolerated dose of Canakinumab.

Primary Outcome Measure

Phase 1b: Maximum Tolerated Dose (MTD) [ Time Frame: up to 28 days per cohort ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Emory-Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLEmory-Winship Cancer Institute· Atlanta, GA

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