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

NCT04342962 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

tagraxofusp

Tagraxofusp is provided as an intravenous (IV) injectable and administered as a 15-minute IV infusion. Cycle 1 will include a 2-day dosing period for the first 3 enrolled patients (Days 1-2), a 2-day plus an optional 3rd day for patients 4-6 (Days 1-2 + Day 3 if patient meets criteria for continued dosing) and a 3-day dosing period for patients 7 and beyond (Days 1-3). Cycle 2 and beyond will include a 5-day dosing period for all patients (Days 1-5). In all cycles and schedules, dose delays up to Day 10 of each cycle will be allowed for resolution of toxicities.

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2024-01-18
Completion
2024-01-18

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342962 on ClinicalTrials.gov