Neoplasms

Blood and Lymph Conditions

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Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Dendritic Cell Tumor

Blastic Plasmacytoid Dendritic Cell

12 mcg/kg/day of tagraxofusp for 5 days, for at least 4 cycles of therapy; each cycle is 21 days.

Patients will receive the study drug until disease progression or in case of toxicity.

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.

tagraxofusp

Paola Fazi

Enrico Crea

Alessandro Rambaldi

Antonio Curti

Chiara Cattaneo

Roberto Massimo Lemoli

Rosa Greco

Nicola Fracchiolla

Maria Paola Martelli

Monica Bocchia

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.

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

Tagraxofusp in Patients With CD123+ or With Blastic Plasmacytoid Dendritic Cell Neoplasm Immunophenotype-like Acute Myeloid Leukemia

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).

Safety analysis according to CTCAE criteria

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia	NCT04342962	Acute Myeloid L...	tagraxofusp	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia	NCT04342962	Acute Myeloid L...	tagraxofusp	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto

Spots Global Cancer Trial Database for blastic plasmacytoid dendritic cell leukemia