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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
Bergamo, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, Italy
The objective response rate (ORR)
Evaluate the activity of tagraxofusp, in terms of ORR (PR + CR + CRi), in patients with CD123+ or BlasticPlasmacytoid Dendritic Cell Neoplasm-like phenotype (BPDCN-IF) Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML).
Time frame: 4 months
Rate of AEs and SAEs
Safety analysis according to CTCAE criteria
Time frame: 28 months
Overall survival (OS)
Overall survival
Time frame: 24 months
Event Free Survival (EFS)
Event Free Survival
Time frame: 24 months
Disease Free Survival (DFS)
Disease Free Survival
Time frame: 24 months from response assessment
Cumulative incidence of relapse (CIR)
Cumulative incidence of relapse
Time frame: 24 months from response assessment
Percentage of patients undergoing allogeneic stem cell transplantation
in MRD-negative CR
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo - Catania
Catania, Italy
Irccs Aou San Martino - Genova - Uo Clinica Ematologica
Genova, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico
Palermo, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Aou Senese - Uoc Ematologia E Trapianti
Siena, Italy