Active not recruitingPHASE2INTERVENTIONAL

Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

This research study is for people with acute myeloid leukaemia (AML), a type of blood cancer. It focuses on patients who are not suitable for the usual intense chemotherapy due to age or other health problems. The current standard treatment for these patients involves two medicines: Venetoclax (VEN) and Azacitidine (AZA). Usually, Azacitidine is given for 7 days in each treatment cycle. This study, called VENAZA-5S, is exploring if reducing the Azacitidine treatment to 5 days instead of 7 days can make a difference. The aim is to see if this change can lessen side effects, particularly infections, and make the treatment easier to stick to, without making it less effective. This could potentially improve quality of life and long-term results for patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Leipzig

Enrolment target

Start

17 May 2023

Estimated completion

01 May 2026

Acute Myeloid Leukemia (AML)

What is this study about?

This study is about a type of blood cancer called Acute Myeloid Leukaemia (AML). AML is a serious condition, and without treatment, it can be life-threatening. The good news is that there are treatments available. However, some people, especially older patients or those with other health issues, might not be strong enough for the standard, very intense chemotherapy.

For these patients, a combination of two medicines – Venetoclax (VEN) and Azacitidine (AZA) – has become a widely used treatment. Currently, Azacitidine is typically given for 7 days in each treatment cycle. While this combination works well, it can sometimes lead to side effects, like infections, which might mean patients have to take breaks from treatment or spend more time in hospital.

This new study, called VENAZA-5S, is looking at a small but potentially important change to this treatment. It aims to see if giving Azacitidine for 5 days instead of 7 during each treatment cycle can still be effective, but with fewer side effects. The hope is that by reducing the days of Azacitidine, patients might have fewer infections, fewer interruptions to their treatment, and fewer hospital stays. This could lead to a better quality of life and possibly even better long-term outcomes. The study will carefully check if this 5-day approach is as good as the 7-day approach, especially regarding its ability to control the AML and how well patients tolerate it.

Key takeaways

This study is for adults with a type of blood cancer called AML.
It's for those who cannot have standard intensive chemotherapy.
The study explores a modified treatment with fewer days of one key drug (Azacitidine).
The goal is to reduce side effects and make treatment easier to handle.
It aims to see if this modified treatment is as effective as the current standard.
Participation involves taking medicines and regular check-ups.

Who may be eligible?

To join this study, doctors will first check if you meet certain criteria. You must have been diagnosed with AML, confirmed by specific tests. You also need to be at least 18 years old and generally expected to live for at least 12 weeks. Importantly, this study is specifically for people who, due to their age or other medical conditions, aren't able to have the usual strong chemotherapy for AML.

There are also reasons why someone might not be able to join. For instance, if you've already had certain treatments for AML or a related condition called myelodysplastic syndrome (MDS) – such as specific chemotherapy, certain targeted therapies, or treatments that change your immune cells – you wouldn't be eligible. However, taking hydroxyurea before for your AML is usually fine.

Also, if your AML is a specific rare type (like acute promyelocytic leukaemia) or has certain genetic changes that are known to respond very well to other standard treatments, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with Acute Myeloid Leukaemia (AML)?
Has my doctor told me I can't have the usual strong chemotherapy for AML?
Am I 18 years old or older?
Have I previously received treatments for AML, apart from hydroxyurea, that might make me ineligible (e.g., other chemotherapy or specific targeted therapies for AML)?
Do I have any specific types of AML that usually respond very well to other standard treatments?

Answer every question to see your result.

What does participation involve?

The information provided is a brief summary and doesn't fully detail the participation process. However, based on the description, participating in this study would involve taking a continuous oral medication (Venetoclax) and receiving injections of Azacitidine for 5 days within each 28-day cycle. You would likely have regular doctor's visits for assessments, blood tests, and to monitor for any side effects. These visits would be important to track how well the treatment is working and how you are feeling. The exact number of visits, specific tests involved, and the full duration of treatment and follow-up are not detailed in this summary but would be explained by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a treatment that could be more tolerable with fewer side effects than the current standard, potentially leading to fewer infections and hospital stays. However, like all medical treatments, there are potential risks, including side effects from the medications, even with the adjusted dosage. Your health will be carefully monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation
Verified postcode
Berlin, Germany
Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
Verified postcode
Chemnitz, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Verified postcode
Cottbus, Germany
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
Verified postcode
Dresden, Germany
Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie
Verified postcode
Heidelberg, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Verified postcode
Leipzig, Germany
Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
Verified postcode
Mönchengladbach, Germany
Rotkreuzklinikum München, III. Medizinische Abteilung
Verified postcode
München, Germany
Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill
Verified postcode
München, Germany
Kliniken Sindelfingen,Medizinische Klinik I
Verified postcode
Sindelfingen, Germany

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia. It's a type of cancer that starts in the bone marrow, which is the soft tissue inside your bones where new blood cells are made.

What's the main difference in this new treatment approach?

The main difference is that one of the medicines, Azacitidine, would be given for 5 days in each treatment cycle instead of the usual 7 days.

Why are they changing the number of days for Azacitidine?

Researchers hope that giving Azacitidine for fewer days might lead to fewer side effects, like infections, and make the treatment easier to manage, while still keeping it effective.

Who is this study for?

This study is for adults with AML who are not suitable for very strong chemotherapy due to their age or other health conditions.

Will I still get good care if I don't join the study?

Yes, regardless of whether you join a study, your doctor will always ensure you receive the best available care for your condition.