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Tests treatment safety and results for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Official title 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
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for blastic plasmacytoid dendritic cell neoplasm (bpdcn).
Also referred to as ABT-199, GDC-0199.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment : patients with skin or...
- Age \>18 years
- Ability to understand the protocol and to sign an informed consent
- Possibility of follow-up
- ECOG \< 3
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- 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
- Known positivity for hepatitis B or C infection except for those people with an undetectable viral load or people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Argenteuil, France
- Avignon, France
- Besançon, France
- Clamart, France
- Clermont-Ferrand, France
- Corbeil-Essonnes, France
- Créteil, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Metz, France
- Montpellier, France
- Mulhouse, France
- Nantes, France
- Nîmes, France
- Paris, France
+ 12 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Argenteuil, France; Avignon, France; Besançon, France; Clamart, France and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.