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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
EU CTIS ID: 2024-511003-42-00
What this study is testing
The primary objective is the efficacy of the tagraxofusp + venetoclax combination (TAGVEN) as measured by the rate of composite complete remission (cCR), defined as complete remission (CR) or complete remission with incomplete marrow recovery (Cri), according to the European Leukemia Net 2022 definitions for AML and adapted for BPDCN) or complete response with minimal residual skin abnormality (CRc[clinical]) defined by a marked clearance of ≥ 75% of a patient’s skin lesions from baseline and a complete metabolic response after 3 cycles of the combination of tagraxofusp and venetoclax (approximatively 12 weeks) or at end of treatment for patients who stop the treatment prematurely in adult patients with a treatment-naive BPDCN.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment ; 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 ≥ 45 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 ; 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
You likely can't join if
- 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.Concomitant immunosuppressive therapy –except for low-dose prednisone (≤10 mg/day) ; 4.Concomitant treatment with medications prohibited in association with venetoclax ; 5.Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients ; 6.Pregnant or breastfeeding woman ; 7.Peripheral neuropathy grade > 2 ; 8. 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 ; 9.Known HIV-positivity ; 10.Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) ; 11.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 ; 12.Subject with a history of other malignancies prior to study ; 13.Malabsorption syndrome or other conditions that preclude enteral route of administration
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.