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Clinical Trials in France / NCT07007052
Recruiting Phase 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

NCT07007052 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2025-12-11
Last updated
2026-07-01

Condition(s) studied

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Investigational drug(s) / intervention(s)

Venetoclax →Tagraxofusp →

Venetoclax: Single interventional arm

Tagraxofusp: Single interventional arm

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. Age \>18 years 3. Ability to understand the protocol and to sign an informed consent 4. Possibility of follow-up 5. ECOG \< 3 6. Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault formula. 7. Adequate cardiac function defined by LVEF \>/= 50% by MUGA or ECHO and no clinically significant abnormalities on a 12-lead ECG 8. Albumin level≥3,2g/dL 9. Adequate liver function as demonstrated by: * aspartate aminotransferase (AST) ≤ 2.5 × ULN\* * alanine aminotransferase (ALT) ≤ 2.5 × ULN\* * bilirubin ≤ 3.0 × ULN, unless due to Gilbert's syndrome\* \* Unless considered due to leukemic organ involvement, in that cases values must be ≤ 10 × ULN 10. Men, and women of childbearing potential must be using a highly effective method of contraception 11. Negative urine/blood pregnancy test within 1 week prior to the initiation of treatment (if applicable) 12. Patient covered by any social security system Exclusion Criteria: 1. Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment. 2. Previous treatment with venetoclax or tagraxofusp 3. Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion 4. Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg/day) 5. Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients. 6. Pregnant or breastfeeding woman 7. 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 8. Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) 9. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to: * Cardiovascular disease e.g., NYHA heart failure \> class 2, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrythmias not controlled by medication. * Renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia. 10. Subject with a history of other malignancies within the last three years prior to study entry, except for: * Adequately treated in situ carcinoma of the breast or cervix uteri * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin * Prostate cancer without needs for specific therapy * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. 11. Malabsorption syndrome or other conditions that preclude enteral route of administration 12. Patient with hereditary fructose intolerance

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
AMIENS - CH Amiens Picardie Site Sud Amiens France Recruiting
ANGERS - CHU - Maladies du sang Angers France Recruiting
ARGENTEUIL - Centre hospitalier Victor Dupouy Argenteuil France Not Yet Recruiting
AVIGNON - Centre Hospitalier Avignon France Not Yet Recruiting
BESANCON - Hôpital Jean Minjoz - Hématologie Besançon France Recruiting
CLAMART - Hôpital d'Instruction des Armées de Percy Clamart France Not Yet Recruiting
Clermont-Ferrand - Chu Estaing Clermont-Ferrand France Not Yet Recruiting
Corbeil-Essonnes - Ch Sud Francilien Corbeil-Essonnes France Not Yet Recruiting
AP-HP- CRETEIL - CHU Henri Mondor Créteil France Recruiting
Grenoble CHU - Hématologie Clinique Grenoble France Not Yet Recruiting
LILLE CHU - Hôpital Claude Huriez Lille France Recruiting
Limoges CHU Limoges France Not Yet Recruiting
LYON HCL- Site Sud Lyon France Recruiting
MARSEILLE - Institut Paoli-Calmettes Marseille France Not Yet Recruiting
METZ - CHR Metz-Thionville Metz France Not Yet Recruiting
Montpellier - Chu Saint Eloi Montpellier France Not Yet Recruiting
MULHOUSE GHRMSA - Hôpital E. Muller - Hématologie Mulhouse France Not Yet Recruiting
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique Nantes France Not Yet Recruiting
Nimes CHU Nîmes France Not Yet Recruiting
APHP - Hôpital Saint-Louis - Hématologie adultes Paris France Not Yet Recruiting
APHP - HOPITAL COCHIN - Hématologie Paris France Not Yet Recruiting
AP-HP - Hôpital Necker Paris France Not Yet Recruiting
BORDEAUX - Hôpital Haut-Levêque Pessac France Recruiting
POITIERS - Hôpital La Milétrie - Hématologie Clinique Poitiers France Not Yet Recruiting
REIMS - Hôpital Robert Debré - Hématologie Clinique Reims France Not Yet Recruiting
RENNES - CHU Pontchaillou - Hématologie Clinique Rennes France Not Yet Recruiting
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique Rouen France Recruiting
CHU SAINT-ETIENNE - iCHUSE Saint-Etienne France Not Yet Recruiting
Strasbourg - Institut de Cancerologie Strasbourg Strasbourg France Not Yet Recruiting
Toulouse - IUCT Oncopole - Service d'Hématologie Toulouse France Not Yet Recruiting
TOURS - Hôpital Bretonneau Tours France Not Yet Recruiting
NANCY - CHU de Brabois Vandœuvre-lès-Nancy France Not Yet Recruiting
VERSAILLES - Hôpital André Mignot Versailles France Not Yet Recruiting
Villejuif Igr - Gustave Roussy Villejuif France Not Yet Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More French Innovative Leukemia Organisation trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007052 on ClinicalTrials.gov ↗ ← All trials in France