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TAGVEN "Open label phase II study evaluating the efficacy and safety of the combination of tagraxofusp and venetoclax in treatment-naive blastic plasmacytoid dendritic cell neoplasm patients"

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511003-42-00
Acronym
TAGVEN
Enrollment
33
Registered
2025-05-26
Start date
2025-12-11
Completion date
Unknown
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASMS

Brief summary

Proportion of participants who achieve a cCR after 3 TAGVEN cycles.

Detailed description

- Objective response rate including cCR and partial remission after 3 TAGVEN cycles - Safety profile of the tagraxofusp and venetoclax combination - Proportion of patients with MRD - Negative responses measured by flow cytometry - Progression-free Survival - Duration of response - Overall Survival - Proportion of patients bridged to allogeneic stem cell transplantation - Possible predictors of response with respect to cytogenetics and mutational status

Interventions

Sponsors

French Innovative Leukemia Organization
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants who achieve a cCR after 3 TAGVEN cycles.

Secondary

MeasureTime frame
- Objective response rate including cCR and partial remission after 3 TAGVEN cycles - Safety profile of the tagraxofusp and venetoclax combination - Proportion of patients with MRD - Negative responses measured by flow cytometry - Progression-free Survival - Duration of response - Overall Survival - Proportion of patients bridged to allogeneic stem cell transplantation - Possible predictors of response with respect to cytogenetics and mutational status

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026