Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04342962|
Recruitment Status : Not yet recruiting
First Posted : April 13, 2020
Last Update Posted : September 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: tagraxofusp||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tagraxofusp in Patients With CD123+ or With Blastic Plasmacytoid Dendritic Cell Neoplasm Immunophenotype-like Acute Myeloid Leukemia|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2025|
Experimental: Experimental arm
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.
- The objective response rate (ORR) [ Time Frame: 4 months ]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).
- Rate of AEs and SAEs [ Time Frame: 28 months ]Safety analysis according to CTCAE criteria
- Overall survival (OS) [ Time Frame: 24 months ]Overall survival
- Event Free Survival (EFS) [ Time Frame: 24 months ]Event Free Survival
- Disease Free Survival (DFS) [ Time Frame: 24 months from response assessment ]Disease Free Survival
- Cumulative incidence of relapse (CIR) [ Time Frame: 24 months from response assessment ]Cumulative incidence of relapse
- Percentage of patients undergoing allogeneic stem cell transplantation [ Time Frame: 12 months ]in MRD-negative CR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342962
|Contact: Paola Fazifirstname.lastname@example.org|
|Contact: Enrico Creaemail@example.com|