TerminatedPhase 2

Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia

Stopped: poor enrollment

Italy25 participantsStarted 2021-02-16

Plain-language summary

Non-randomized, open-label, multicenter phase II Study for the treatment of * 25 R/R BPDCN-IF (CD123/CD4/CD56 positive) AML patients and * 25 patients presenting R/R AML CD123+, but negative for either, or both, CD4 and CD56. Patients will be treated with 12 mcg/kg/day of tagraxofusp for 5 days, for at least 4 cicles.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography(ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
✓. Serum creatinine ≤1.5 mg/dL (133 μmol/L).
✓. Serum albumin ≥3.2 g/dL (32 g/L) (albumin infusions are not permitted to enable eligibility).
✓. Bilirubin ≤1.5 mg/dL (26 μmol/L).
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN).

What they're measuring

The objective response rate (ORR)

Timeframe: 4 months

Trial details

NCT IDNCT04342962

SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-18

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