Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Phase 2TAGVENNCT07007052
Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients
A Phase 2 study testing Venetoclax and Tagraxofusp in people with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by French Innovative Leukemia Organisation at 34 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- What is being tested?
- Venetoclax and Tagraxofusp
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 34 sitesFrance
- Study dates
- 11 Dec 2025to 2 Oct 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
- 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
- Men, and women of childbearing potential must be using a highly effective method of contraception
- Negative urine/blood pregnancy test within 1 week prior to the initiation of treatment (if applicable)
- Patient covered by any social security system
Who cannot join
- Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.
- 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
Show all 18Show fewer
- 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)
- 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.
- 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.
- Malabsorption syndrome or other conditions that preclude enteral route of administration
- Patient with hereditary fructose intolerance
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
France34 sites, 34 recruiting
- Recruiting
AMIENS - CH Amiens Picardie Site Sud
Amiens, 80054
Jean-Pierre Marolleau, Professor, +33 03 22 45 59 14, marolleau.jean-pierre@chu-amiens.fr
- Recruiting
ANGERS - CHU - Maladies du sang
Angers, 49933
Mathilde HUNAULT, Dr, 02 41 35 45 82, mahunault@chu-angers.fr
- Not yet recruiting
ARGENTEUIL - Centre hospitalier Victor Dupouy
Argenteuil
Benjamin PAPOULAR, Doctor, Benjamin.papoular@ch-argenteuil.fr
- Not yet recruiting
AVIGNON - Centre Hospitalier
Avignon, 84000
Safia CHEBREK, Dr, +33 4 32 75 93 00, chebrek.safia@ch-avignon.fr
- Recruiting
BESANCON - Hôpital Jean Minjoz - Hématologie
Besançon, 25030
Eric DECONINCK, Professor, +33 03 81 66 82 32, edeconinck@chu-besancon.fr
- Not yet recruiting
CLAMART - Hôpital d'Instruction des Armées de Percy
Clamart, 92140
Justine SIAVELLIS, Dr, +33 01 41 46 63 01, justine.siavellis@intradef.gouv.fr
- Not yet recruiting
Clermont-Ferrand - Chu Estaing
Clermont-Ferrand, 63000
Aurelie RAVINET, Dr, +33 04 73 75 00 65, aravinet@chu-clermontferrand.fr
- Not yet recruiting
Corbeil-Essonnes - Ch Sud Francilien
Corbeil-Essonnes
Célia SALANOUBAT, Dr, +33 01 61 69 87 71, celia.salanoubat@chsf.fr
- Recruiting
AP-HP- CRETEIL - CHU Henri Mondor
Créteil, 94000
Mathieu LECLER, Dr, +33 01 49 81 20 57, mathieu.lecler@aphp.fr
- Not yet recruiting
Grenoble CHU - Hématologie Clinique
Grenoble, 38043
Martin CARRE, Dr, +33 4 76 76 57 55, mcarre1@chu-grenoble.fr
- Recruiting
LILLE CHU - Hôpital Claude Huriez
Lille, 59037
Céline Berthon, Dr, +33 03 20 44 42 90, Celine.BERTHON@chu-lille.fr
- Not yet recruiting
Limoges CHU
Limoges
Pascal Turlure, Dr, pascal.turlure@chu-limoges.fr
- Recruiting
LYON HCL- Site Sud
Lyon
Mael Heiblig, Pr, +33(0)4 78 86 22 33, mael.heiblig@chu-lyon.fr
- Not yet recruiting
MARSEILLE - Institut Paoli-Calmettes
Marseille, 13000
Valerio MAISANO, Dr, +33 04 91 22 37 54, maisanov@ipc.unicancer.fr
- Not yet recruiting
METZ - CHR Metz-Thionville
Metz, 57085
Houria DEBARRI, MD, h.debarri@chr-metz-thionville.fr
- Not yet recruiting
Montpellier - Chu Saint Eloi
Montpellier
Sarah BONNET, Dr, +33 04 67 33 83 54, sarah.bonnet@chu-montpellier.fr
- Not yet recruiting
MULHOUSE GHRMSA - Hôpital E. Muller - Hématologie
Mulhouse, 68070
Mario OJEDA-URIBE, Dr, +33(0)3 89 64 77 55, ojeda-uribem@ghrmsa.fr
- Not yet recruiting
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique
Nantes, 44093
Alice GARNIER, Dr, +33(0)2 40 08 32 71, alice.garnier@chu-nantes.fr
- Not yet recruiting
Nimes CHU
Nîmes
Samy CHRAIBI, Dr, +33 04 66 68 40 33, samy.chraibi@chu-nimes.fr
- Not yet recruiting
APHP - Hôpital Saint-Louis - Hématologie adultes
Paris, 75010
Lionel ADES, Dr, +33 01 71 20 70 21, lionel.ades@aphp.fr
- Not yet recruiting
APHP - HOPITAL COCHIN - Hématologie
Paris, 75014
Justine DECROOCQ, Dr, +33(0)1 58 41 21 31, justine.decroocq@aphp.fr
- Not yet recruiting
AP-HP - Hôpital Necker
Paris, 75015
Felipe SUAREZ, felipe.suarez@aphp.fr
- Recruiting
BORDEAUX - Hôpital Haut-Levêque
Pessac, 33600
Pierre-Yves DUMAS, Pr, +33 05 57 64 91 62, yves.dumas@chu-bordeaux.fr
- Not yet recruiting
POITIERS - Hôpital La Milétrie - Hématologie Clinique
Poitiers, 86000
Maria-Pilar GALLEGO-HERNANZ, Dr, +33(0)5 49 44 44 44, maria-pilar.gallego-hernanz@chu-poitiers.fr
- Not yet recruiting
REIMS - Hôpital Robert Debré - Hématologie Clinique
Reims, 51100
Chantal HIMBERLIN, Dr, +33(0)3 26 78 36 44, chimberlin@chu-reims.fr
- Not yet recruiting
RENNES - CHU Pontchaillou - Hématologie Clinique
Rennes, 35033
Jean-Baptiste MEAR, Dr, +33 02 99 28 72 91, jean-baptiste.mear@chu-rennes.fr
- Recruiting
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique
Rouen, 76038
Emilie LEMASLE, Dr, +33 2 32 08 22 21, emilie.lemasle@chb.unicancer.fr
- Not yet recruiting
CHU SAINT-ETIENNE - iCHUSE
Saint-Etienne, 42271
Emmanuelle TAVERNIER, Dr, +33 04 77 91 70 60, emmanuelle.tavernier@chu-st-etienne.fr
- Not yet recruiting
Strasbourg - Institut de Cancerologie Strasbourg
Strasbourg, 67200
Célestine Pierre SIMAND, Dr, +33 03 68 76 74 07, c.simand@icans.eu
- Not yet recruiting
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse
Christian RECHER, Prof, recher.christian@iuct-oncopole.fr
- Not yet recruiting
TOURS - Hôpital Bretonneau
Tours, 37000
Alban VILLATE, MD, a.villate@chu-tours.fr
- Not yet recruiting
NANCY - CHU de Brabois
Vandœuvre-lès-Nancy, 54500
Caroline BONMATI, Dr, c.bonmati@chru-nancy.fr
- Not yet recruiting
VERSAILLES - Hôpital André Mignot
Versailles
Fatiha MERABET, Dr, +33 01 39 63 89 09, fmerabet@ght78sud.fr
- Not yet recruiting
Villejuif Igr - Gustave Roussy
Villejuif, 94804
David GHEZ, Dr, +33 01 42 21 42 40, david.ghez@gustaveroussy.fr
About this study
Official title: 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
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.
- Being tested
- Venetoclax, Tagraxofusp
- Keywords
- blastic plasmacytoid dendritic cell neoplasm, Combination of venetoclax + tagraxofusp, Composite complete remission, Complete remission, Evaluation of response
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199, RG7601, selective BCL-2 inhibitor
Single interventional arm
TagraxofuspDrug
Also called SL-401, CD123-directed cytotoxin
Single interventional arm
| Study group | Role | What they receive |
|---|---|---|
| Single interventional arm | Experimental | 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 Receives: Drug: Venetoclax; Drug: Tagraxofusp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles
Evaluation will be done with a bone marrow aspirate, cytogenetics, metabolic imaging, study of MRD by NGS and flow-cytometry and SWAT SCORE
Measured: From enrollment to the end of the third 28 days-cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start11 Dec 2025
- Primary completion10 Dec 2028 (estimated)
- Study completion2 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Stemline Therapeutics, Inc., AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007052
- Sponsor's protocol ID
- TAGVEN
- Acronym
- TAGVEN
- Status last verified
- Jun 2026
- First submitted
- 28 May 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected will be analyzed by the sponsor and therefore not shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07007052
- Acronym / sponsor ID
- TAGVEN / TAGVEN
- Keywords
- blastic plasmacytoid dendritic cell neoplasm, Combination of venetoclax + tagraxofusp, Composite complete remission, Complete remission, Evaluation of response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Stemline Therapeutics, Inc., AbbVie
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 2 Oct 2031 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single interventional arm | Experimental | Drug: Venetoclax, Drug: TagraxofuspFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (18 listed)
- Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: ABT-199, GDC-0199, RG7601, selective BCL-2 inhibitorSingle interventional arm | Drug | Single interventional arm |
| TagraxofuspAlso: SL-401, CD123-directed cytotoxinSingle interventional arm | Drug | Single interventional arm |
Primary outcome
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
Evaluation will be done with a bone marrow aspirate, cytogenetics, metabolic imaging, study of MRD by NGS and flow-cytometry and SWAT SCORE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. The individual participant data collected will be analyzed by the sponsor and therefore not shared.
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A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AMIENS - CH Amiens Picardie Site Sud
Amiens, France
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax and Tagraxofusp in people with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by French Innovative Leukemia Organisation at 34 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.