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Promising combo targets rare blood cancer in early trial

NCT ID NCT07007052

Disease control Sponsor: French Innovative Leukemia Organisation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a two-drug combination (tagraxofusp and venetoclax) in adults with a rare and aggressive blood cancer called BPDCN who have not had prior treatment. The main goal is to see if the combination can achieve complete remission after 3 months. Depending on results, patients may continue treatment, receive a stem cell transplant, or stop therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Blastic Plasmacytoid Dendritic Cell Neoplasm CD4+/CD56+ hematodermic neoplasm Pathologic Complete Response

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMIENS - CH Amiens Picardie Site Sud

    RECRUITING

    Amiens, 80054, France

  • ANGERS - CHU - Maladies du sang

    RECRUITING

    Angers, 49933, France

  • AP-HP - Hôpital Necker

    NOT_YET_RECRUITING

    Paris, 75015, France

  • AP-HP- CRETEIL - CHU Henri Mondor

    RECRUITING

    Créteil, 94000, France

  • APHP - HOPITAL COCHIN - Hématologie

    NOT_YET_RECRUITING

    Paris, 75014, France

  • APHP - Hôpital Saint-Louis - Hématologie adultes

    NOT_YET_RECRUITING

    Paris, 75010, France

  • ARGENTEUIL - Centre hospitalier Victor Dupouy

    NOT_YET_RECRUITING

    Argenteuil, France

  • AVIGNON - Centre Hospitalier

    NOT_YET_RECRUITING

    Avignon, 84000, France

  • BESANCON - Hôpital Jean Minjoz - Hématologie

    RECRUITING

    Besançon, 25030, France

  • BORDEAUX - Hôpital Haut-Levêque

    RECRUITING

    Pessac, 33600, France

  • CHU SAINT-ETIENNE - iCHUSE

    NOT_YET_RECRUITING

    Saint-Etienne, 42271, France

  • CLAMART - Hôpital d'Instruction des Armées de Percy

    NOT_YET_RECRUITING

    Clamart, 92140, France

  • Clermont-Ferrand - Chu Estaing

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63000, France

  • Corbeil-Essonnes - Ch Sud Francilien

    NOT_YET_RECRUITING

    Corbeil-Essonnes, France

  • Grenoble CHU - Hématologie Clinique

    NOT_YET_RECRUITING

    Grenoble, 38043, France

  • LILLE CHU - Hôpital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • LYON HCL- Site Sud

    RECRUITING

    Lyon, France

  • Limoges CHU

    NOT_YET_RECRUITING

    Limoges, France

  • MARSEILLE - Institut Paoli-Calmettes

    NOT_YET_RECRUITING

    Marseille, 13000, France

  • METZ - CHR Metz-Thionville

    NOT_YET_RECRUITING

    Metz, 57085, France

  • MULHOUSE GHRMSA - Hôpital E. Muller - Hématologie

    NOT_YET_RECRUITING

    Mulhouse, 68070, France

  • Montpellier - Chu Saint Eloi

    NOT_YET_RECRUITING

    Montpellier, France

  • NANCY - CHU de Brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • Nimes CHU

    NOT_YET_RECRUITING

    Nîmes, France

  • POITIERS - Hôpital La Milétrie - Hématologie Clinique

    NOT_YET_RECRUITING

    Poitiers, 86000, France

  • REIMS - Hôpital Robert Debré - Hématologie Clinique

    NOT_YET_RECRUITING

    Reims, 51100, France

  • RENNES - CHU Pontchaillou - Hématologie Clinique

    NOT_YET_RECRUITING

    Rennes, 35033, France

  • ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

    RECRUITING

    Rouen, 76038, France

  • Strasbourg - Institut de Cancerologie Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67200, France

  • TOURS - Hôpital Bretonneau

    NOT_YET_RECRUITING

    Tours, 37000, France

  • Toulouse - IUCT Oncopole - Service d'Hématologie

    NOT_YET_RECRUITING

    Toulouse, France

  • VERSAILLES - Hôpital André Mignot

    NOT_YET_RECRUITING

    Versailles, France

  • Villejuif Igr - Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94804, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.