Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and safety of obinutuzumab versus rituximab in combination with chemotherapy for adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia

This study is for adults who have recently been diagnosed with a type of blood cancer called acute lymphoblastic leukaemia. Researchers are comparing two different treatments, obinutuzumab and rituximab, which will be given alongside standard chemotherapy. The main goal is to find out which combination is better at getting the cancer to go away (into remission) after the first stage of treatment. They will also look at how many cancer cells are left after treatment, how long people stay healthy, and any side effects. This is a Phase II study, meaning it's an important step in seeing if these treatments are safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Enrolment target

124

Start

07 Oct 2024

acute lymphoblastic leukemia

What is this study about?

This study is focused on a type of blood cancer called acute lymphoblastic leukaemia (ALL) that affects adults. When someone is diagnosed with ALL, doctors often use a combination of treatments to try and get rid of the cancer. This particular study is comparing two different new treatments, obinutuzumab and rituximab, which will be added to the standard chemotherapy that patients would normally receive.

The main aim is to see how well these combinations work in putting the cancer into something called 'complete remission'. This means there are no signs of the cancer in the body. They will specifically look at how many cancer cells are left in the bone marrow after the first round of treatment, using a very sensitive test called MRD (minimal residual disease). A lower number of these remaining cancer cells is generally a good sign.

Beyond the initial remission, the study will also track things like how long patients stay in remission, their overall health over 24 months, and any side effects they might experience. This information helps doctors understand which treatments are most effective and safest for people with adult ALL.

Key takeaways

This study compares two treatments (obinutuzumab vs. rituximab) plus chemotherapy for adult ALL.
The main goal is to find which combination best puts the cancer into remission.
Researchers will check for very small amounts of cancer cells after treatment.
The study also tracks overall health, survival, and side effects over 2 years.
It's for adults newly diagnosed with acute lymphoblastic leukaemia.

Who may be eligible?

This study is looking for adult patients who have recently been diagnosed with acute lymphoblastic leukaemia (ALL).

If you are 18 years old or older, you might be able to take part. The study is open to both men and women.

It's important to remember that there will be other specific medical checks to make sure the study is right and safe for you. Your doctor can help you understand if you meet all the requirements.

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.

Are you 18 years old or older?
Have you recently been diagnosed with acute lymphoblastic leukaemia (ALL)?
Are you generally healthy enough to receive chemotherapy and study drugs?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will explain everything in detail. You will receive either obinutuzumab or rituximab, along with your usual chemotherapy, as part of your treatment. This will involve regular visits to the hospital for your treatments, blood tests, and other check-ups.

Throughout the study, doctors will closely monitor your health, looking at how your cancer responds to treatment and any side effects you might experience. This will include tests like bone marrow samples to check for remaining cancer cells. You will also have follow-up appointments and assessments over a period of 24 months to see how you are doing in the longer term. The total duration of your participation in terms of follow-up will be two years.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could be more effective than existing options, or it could help shed light on better ways to treat adult ALL. However, as with any medical treatment, there are potential risks, including side effects from the medications. The research team will monitor you very closely for any problems. You will always have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Poland

Common questions

What is acute lymphoblastic leukaemia (ALL)?

ALL is a type of cancer that starts in the white blood cells in your bone marrow.

What does 'complete remission' mean?

Complete remission means that tests can no longer find any signs of the cancer in your body.

What is MRD testing?

MRD stands for minimal residual disease. It's a very sensitive test to find small numbers of cancer cells that might still be in your body after treatment.

What is a Phase II study?

A Phase II study is an important step that checks if a new treatment is safe and effective in a larger group of patients.

Will I have to pay to be in the study?

No, participation in clinical trials is usually free, and the medications and tests related to the study are covered.