Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetocla… (NCT07007052) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients
France33 participantsStarted 2025-12-01
Plain-language summary
The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients.
The main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment.
Patients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment : patients with skin or lymph node lesions but no bone marrow involvement can be included
✓. Age \>18 years
✓. Ability to understand the protocol and to sign an informed consent
✓. Possibility of follow-up
✓. ECOG \< 3
✓. Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault formula.
✓. Adequate cardiac function defined by LVEF \>/= 50% by MUGA or ECHO and no clinically significant abnormalities on a 12-lead ECG
✓. Albumin level≥3,2g/dL
Exclusion criteria
✕. Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.
✕
What they're measuring
1
Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles
Timeframe: From enrollment to the end of the third 28 days-cycle
. Previous treatment with venetoclax or tagraxofusp
✕. Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion
✕. Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg/day)
✕. Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients.
✕. Pregnant or breastfeeding woman
✕. Known positivity for hepatitis B or C infection except for those subjects with an undetectable viral load or subjects with serologic evidence of prior vaccination to HBV
✕. Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal)