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Study of Azacitidine, Venetoclax, and Tagraxofusp for Patients with Higher-Risk Chronic Myelomonocytic Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called chronic myelomonocytic leukemia (CMML), which is considered higher-risk. The study will explore the effects of combining three treatments: azacitidine (AZA), venetoclax (VEN), and tagraxofusp (TAG). Azacitidine is a standard treatment for certain blood disorders, while venetoclax and tagraxofusp are additional medications being tested for their effectiveness in this combination.

The purpose of the study is to gather information on how well these treatments work together in patients with higher-risk CMML. Participants will receive these medications over a period of up to 12 months. The study will monitor the response to the treatment, including any changes in the disease and overall health. The medications will be given in different forms: venetoclax as a film-coated tablet taken by mouth, and tagraxofusp as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The study aims to understand the potential benefits and risks of this treatment combination, as well as its impact on the quality of life for those with higher-risk CMML. The results will help determine if this combination of treatments can be a viable option for managing this type of leukemia.

1 initiation of treatment

The treatment begins with the administration of azacitidine (AZA), venetoclax (VEN), and tagraxofusp (TAG).

Azacitidine is given as part of the standard care for patients with higher-risk chronic myelomonocytic leukemia (CMML).

2 medication administration

Venetoclax is taken orally in the form of film-coated tablets.

Tagraxofusp is administered through an intravenous (IV) infusion as a solution for infusion.

3 treatment cycles

The treatment is organized into cycles. Each cycle includes the administration of the medications as described.

The primary outcome measure is assessed after 3 cycles of treatment, focusing on the response rate.

4 monitoring and assessment

Throughout the trial, regular monitoring of adverse events, clinical laboratory values, vital signs, and heart function is conducted.

The response to treatment is evaluated using specific criteria to determine the effectiveness of the therapy.

5 evaluation of outcomes

The primary outcome is the response rate after 3 cycles, defined as complete response (CR), marrow complete response (mCR), or partial response (PR).

Secondary outcomes include overall survival, time to leukemia transformation, and changes in quality of life after 3 and 12 cycles.

Who Can Join the Study?

  • Must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
  • Must be 18 years or older at the time of signing the informed consent.
  • Must be able to follow the study visit schedule and other study requirements.
  • Must have a diagnosis of chronic myelomonocytic leukemia (CMML) according to the World Health Organization (WHO) 2022 criteria.
  • Must have a CPSS risk of intermediate-2 or high for CMML at the start of the study. CPSS is a scoring system used to assess the risk level of CMML.
  • Must be eligible for and will receive azacitidine (AZA) as part of the standard treatment.
  • Must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale, which measures how well you can perform daily activities.
  • Must have adequate organ function, including:
    • Liver: Total bilirubin less than 1.5 times the upper limit of normal, and liver enzymes (ALT and AST) less than 2.5 times the upper limit of normal.
    • Kidneys: Creatinine clearance of 45 mL/minute or higher, which measures how well your kidneys are working.
    • Heart: Left ventricular ejection fraction (LVEF) of 50% or higher, which measures how well your heart pumps blood, and no significant abnormalities on an electrocardiogram (ECG).
    • Albumin: Serum albumin level of 3.2 g/dL or higher, which is a protein in your blood.
  • Must have available blood counts and transfusion records for the previous 8 weeks.
  • Women who can have children must use a highly effective method of birth control during the study and for 6 months after the last dose. They must also have a negative pregnancy test before starting treatment and agree to regular pregnancy tests during the study.
  • Men who are sexually active with women who can have children must use a highly effective method of birth control during the study and for 3 months after the last dose. They must also agree not to donate sperm during this time.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than chronic myelomonocytic leukemia cannot participate. This is a specific type of blood cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not included in the study.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliero Universitaria Careggi Florence Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
ASST Fatebenefratelli Sacco Milan Italy
Aneejee Uuzya Sariydpxs Lspflz Dn Bhfiyrz Bologna Italy
Fmbyynxdq Pgpi Lx Ipyemubanzttw Bewukfftr Dxm Hkjlzaip Uqpohjmawdfjt Lm Pta Madrid Spain
Idntnblo Cezlfe Dvgrdoiazycnhqrkn L'hospitalet De Llobregat Spain

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.02.2025
Italy Italy
Recruiting
01.02.2025
Spain Spain
Recruiting
01.02.2025

Trial locations

Investigated drugs:

Azacitidine is a medication used to treat certain types of blood disorders. It works by helping to restore normal growth of blood cells and reducing the number of abnormal blood cells. In this trial, it is part of the standard care therapy for patients with higher-risk chronic myelomonocytic leukemia.

Venetoclax is a medication that helps to kill cancer cells by blocking a protein that helps them survive. It is used in combination with other treatments to improve their effectiveness in treating certain types of leukemia.

Tagraxofusp is a medication that targets specific cancer cells and helps to destroy them. It is used in this trial to see if it can improve outcomes for patients with higher-risk chronic myelomonocytic leukemia when combined with other treatments.

Chronic Myelomonocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by an increase in monocytes, a type of white blood cell. It typically progresses slowly, with symptoms that may include fatigue, fever, and weight loss. Over time, the disease can lead to anemia, increased risk of infections, and bleeding issues due to low blood cell counts. The bone marrow, which is responsible for producing blood cells, becomes dysfunctional, leading to an imbalance in blood cell production. As the disease advances, it may transform into acute myeloid leukemia, a more aggressive form of blood cancer. The progression and symptoms can vary significantly among individuals.

Trial ID:
2024-511102-22-00
Protocol code:
PATROL
Trial Phase:
Therapeutic exploratory (Phase II)

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