Study on the Effectiveness and Safety of Tagraxofusp and Venetoclax for Adults with Untreated Blastic Plasmacytoid Dendritic Cell Neoplasm

2 1 1 1

What is this study about?

This clinical trial is focused on studying a rare type of blood cancer called Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The study will evaluate the effectiveness and safety of a combination of two treatments: tagraxofusp and venetoclax. Tagraxofusp is a medication that targets specific cells in the body, while venetoclax is a type of drug known as a BCL-2 inhibitor, which helps to kill cancer cells. The purpose of the study is to see how well these two medications work together in patients who have not received any previous treatment for BPDCN.

Participants in the study will receive both tagraxofusp and venetoclax over a period of time. Tagraxofusp is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while venetoclax is taken orally as a tablet. The study will monitor how patients respond to the treatment combination, looking for signs of improvement in their condition. The trial will also assess the safety of the treatment, checking for any side effects that may occur.

The study aims to determine the rate of complete remission, which means the cancer is no longer detectable, or a significant reduction in cancer symptoms after three cycles of treatment. Researchers will also look at other outcomes, such as how long patients remain free from cancer progression and overall survival rates. This trial is an important step in finding more effective treatments for BPDCN and improving the quality of life for those affected by this rare cancer.

1 beginning of the trial

Upon joining the clinical trial, the patient will start the treatment with a combination of two medications: tagraxofusp and venetoclax. These medications are used to treat a condition known as blastic plasmacytoid dendritic cell neoplasm (BPDCN).

2 medication administration

Tagraxofusp is administered through an intravenous (IV) infusion. This means the medication is given directly into the bloodstream through a vein. The specific dosage and frequency of administration will be determined by the healthcare team based on the patient’s individual needs.

Venetoclax is taken orally in the form of film-coated tablets. The dosage and frequency will also be determined by the healthcare team. It is important to follow the instructions provided by the healthcare team regarding how and when to take this medication.

3 treatment cycles

The treatment is organized into cycles. Each cycle consists of a specific period during which the medications are administered, followed by a rest period. The primary goal is to evaluate the effectiveness and safety of the medication combination after three cycles.

During these cycles, the healthcare team will monitor the patient’s response to the treatment and any side effects that may occur. This monitoring is crucial to ensure the patient’s safety and to make any necessary adjustments to the treatment plan.

4 evaluation of response

After completing three cycles of treatment, the healthcare team will assess the patient’s response. The main objective is to determine if there is a complete remission, which means the absence of disease symptoms, or a significant reduction in skin lesions.

The evaluation will include various tests and assessments to measure the effectiveness of the treatment and to check for any remaining disease activity.

5 ongoing monitoring

Throughout the trial, the patient will undergo regular check-ups and tests to monitor their health and the progress of the treatment. This includes blood tests, imaging studies, and other assessments as needed.

The healthcare team will provide guidance and support to manage any side effects and to ensure the patient’s well-being during the trial.

Who Can Join the Study?

  • Patients must have a confirmed diagnosis of Blastic Plasmacytoid Dendritic Cell Neoplasms (BPDCN) according to the World Health Organization (WHO) 2022 criteria and have not received previous treatment.
  • Patients must be older than 18 years.
  • Patients must be able to understand the study details and sign an informed consent form.
  • Patients must be able to attend follow-up appointments.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than 3. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
  • Patients must have adequate kidney function, shown by a creatinine clearance of at least 45 mL/min. This is a measure of how well the kidneys are working.
  • Patients must have adequate heart function, defined by a Left Ventricular Ejection Fraction (LVEF) of 50% or higher, as measured by a heart scan (MUGA or ECHO), and no significant abnormalities on an electrocardiogram (ECG).
  • Patients must have an albumin level of at least 3.2 g/dL. Albumin is a protein in the blood that helps maintain fluid balance.
  • Patients must have adequate liver function.
  • Men and women who can have children must use a highly effective method of birth control.
  • Women must have a negative urine or blood pregnancy test within one week before starting treatment.

Who Cannot Join the Study?

  • Patients who have any other serious medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer within the last 2 years, except for certain skin cancers.
  • Patients who have an active infection that requires treatment.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a known allergy to the study drugs or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse within the last 6 months.
  • Patients who have a mental health condition that could interfere with their ability to participate in the study.
  • Patients who have received certain treatments for their condition within a specific time frame before the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
CHU d’Estaing Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Hopital Necker Enfants Malades Paris France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital D’Instruction Des Armees Percy Clamart France
Centre Hospitalier D Avignon Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Lyon Sud Pierre Benite France
Oncoradio Centre Oncogard Nimes France
Hôpital Pontchaillou-CHU Rennes Rennes France
Centre Hospital Region Metz Thionville Metz France
Cxndou Hiwvikrkryf Udpgfruwgdogo Rtlno Reims France
Hwdrsby Htvtr Mbhvft &ignjfp 1 rzp Gytwsnr Edenbl Creteil France
Cgghkf Hwadkzigwil Ek Uzbrmhovqnods Dy Lyqauyt Limoges France
Aysxzqfsdw Pyhnubbq Helxbfdh Dn Pqzwm Paris France
Alxmblqwzn Pqnckffx Hqghhoui Ds Pzyhq Paris France
Bdathydh Unegaiufcr Hhklkdbp Cwzcgj Besançon France
Cjxl Do Nckbb Vandoeuvre Les Nancy France
Ccwjte Hhfwovgkima Rywhbnjp Dgrmpqgxoacohv Angers France
Ixoztiir dz Cqnuvbctrsiy Hkatxmgluwv Utrdinnqhjjwf dq Skxgu Eskvrgj (nyfubsi Saint Priest En Jarez France
Isxkzjmc Pakcryvqttzrekw Cxopcp Claijd Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
31.01.2025

Trial locations

Investigated drugs:

Tagraxofusp is a medication used in this clinical trial to treat a rare type of blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN). It works by targeting and killing cancer cells. Tagraxofusp is designed to attach to a specific protein found on the surface of these cancer cells, helping to destroy them and reduce the number of cancer cells in the body.

Venetoclax is another medication used in the trial, which helps to treat BPDCN by targeting a protein that prevents cancer cells from dying. By blocking this protein, venetoclax encourages the cancer cells to die naturally, which can help to reduce the number of cancer cells and slow down the progression of the disease. This medication is used in combination with tagraxofusp to enhance the overall effectiveness of the treatment.

Blastic Plasmacytoid Dendritic Cell Neoplasms – This is a rare type of blood cancer that originates from a specific type of immune cell known as plasmacytoid dendritic cells. It typically presents with skin lesions, which may appear as purple or red patches, nodules, or ulcers. The disease can progress to involve the bone marrow and blood, leading to symptoms such as fatigue, fever, and weight loss. As it advances, it may cause a decrease in blood cell counts, resulting in anemia, increased risk of infections, and bleeding issues. The progression of the disease can vary, with some cases remaining localized to the skin for a period, while others rapidly spread to other parts of the body. Understanding the behavior of this disease is crucial for managing its impact on the patient’s health.

Trial ID:
2024-511003-42-00
Protocol code:
TAGVEN
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of SAR443579 Infusion for Adults and Children with Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia, HR-MDS, or BPDCN

    Not recruiting

    2 1 1 1
    France The Netherlands