Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT07007052
Phase
PHASE2
Status
Recruiting
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Conditions

  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Single interventional arm
  • Tagraxofusp — DRUG
    Single interventional arm

Study Details

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.

Key Dates

First listed
Jun 5, 2025
Start date
Dec 11, 2025
Status verified
Jun 2026
Primary completion
Dec 10, 2028
Completion
Oct 2, 2031

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single interventional arm
    For each 28 days-cycle of treatment : * venetoclax 400mg/day orally after a ramp-up period of 3-days * tagraxofusp starting at the end of the venetoclax ramp-up period i.e. at day 4 for twelve 28-days cycles, 12 μg/kg body weight administered as an intravenous infusion over 15 minutes, once daily, on days 1-3 of each cycle

Primary Outcome Measure

Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles [ Time Frame: From enrollment to the end of the third 28 days-cycle ]

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