Active not recruitingPHASE3INTERVENTIONAL

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

This research study is for older adults with a specific type of blood cancer called Philadelphia-negative B-cell precursor acute lymphoblastic leukaemia (ALL) that has been recently diagnosed. The study wants to find out if a treatment plan using a drug called Blinatumomab, given alongside a lighter chemotherapy, is safer and works better than the standard chemotherapy treatment currently given. Researchers will specifically look at how long people live without their cancer coming back (event-free survival) and how long they live overall (overall survival). This study is in its final phase (Phase 3), meaning it's comparing the new approach against the established treatment to see if it could become a new standard of care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

303

Start

02 Nov 2021

Estimated completion

12 May 2031

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

What is this study about?

This study is about finding better ways to treat a type of blood cancer called B-cell precursor acute lymphoblastic leukaemia (ALL) in older adults. This specific type of ALL is 'Philadelphia-negative', which is just a way doctors classify the cancer. When you’re diagnosed with a serious condition like this, doctors always want to find the most effective and safest treatment for you.

Currently, there’s a 'standard of care' chemotherapy treatment used. However, this study is exploring a different approach. It involves a drug called Blinatumomab, which works by helping your own immune system fight the cancer cells. This drug is given alongside a lower, less intensive dose of chemotherapy. The idea is that this combination might be gentler on the body while still being very effective against the cancer.

The main goal of this research is to compare these two treatment approaches. Doctors want to see if the Blinatumomab and low-intensity chemotherapy combination can help people live longer without their cancer returning, and also help them live longer overall, compared to the standard chemotherapy. This could potentially offer a new, more manageable treatment option for older adults with this type of leukaemia.

Key takeaways

This study is for older adults with a specific type of newly diagnosed blood cancer (ALL).
It compares a new treatment (Blinatumomab + gentler chemotherapy) against standard chemotherapy.
The main goal is to see if the new treatment helps people live longer without their cancer returning and live longer overall.
Eligibility is based on age and overall health, especially kidney, liver, and heart function.
Participation involves regular checks and monitoring of health and treatment effects.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with a specific type of blood cancer called Philadelphia-negative B-cell precursor acute lymphoblastic leukaemia (ALL).

You must be at least 55 years old to take part. However, if you are aged between 40 and younger than 55, you might also be able to join if you have certain other health conditions. These could include a history of severe pancreatitis, diabetes that has affected your organs, serious liver disease (like cirrhosis), or a very high Body Mass Index (BMI) along with other related health issues. Doctors will review your overall health to decide if the study treatment would be suitable for you.

To ensure your safety, your body needs to be working well enough to handle the treatments. This means your kidneys, liver, and heart function will be checked to make sure they are healthy enough for you to safely participate.

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 55 years or older?
If you're between 40 and 55, do you have certain other health conditions like severe diabetes, liver problems, or a high BMI?
Have you recently been diagnosed with Philadelphia-negative B-cell precursor ALL?
Are your kidneys, liver, and heart working well enough to be part of a study?
Are you generally able to carry out daily activities with little to no difficulty, even if your leukaemia makes some things harder?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new treatment combination (Blinatumomab plus low-intensity chemotherapy) or the standard chemotherapy treatment. Which treatment you receive is decided randomly, like flipping a coin. You wouldn't get to choose, and neither would your doctor. The study regularly checks your health through blood tests, scans, and physical examinations. This is to monitor how you're responding to the treatment and to check for any side effects. The duration of treatment and follow-up will vary depending on which group you are in, and your doctor will explain the full schedule to you.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of accessing new treatments before they are widely available, which could be more effective or have fewer side effects than current standard care. However, like all medical treatments, there are potential risks and side effects associated with both the experimental and standard treatments. Researchers will closely monitor your health throughout the study to manage any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (192)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California Irvine
Verified postcode
Orange, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Verified postcode
Orlando, United States
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
Saint Francis Hospital, Inc
Verified postcode
Greenville, United States
University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
Canberra Hospital
Verified postcode
Garran, Australia
Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia
Liverpool Hospital
Verified postcode
Liverpool, Australia
Royal North Shore Hospital
Verified postcode
St Leonards, Australia
Westmead Hospital
Verified postcode
Westmead, Australia

Common questions

What is Philadelphia-negative B-cell precursor acute lymphoblastic leukaemia (ALL)?

It's a type of fast-growing blood cancer that affects certain white blood cells. 'Philadelphia-negative' simply describes a specific genetic feature that helps doctors classify the cancer.

What is Blinatumomab and how does it work?

Blinatumomab is a specific drug that helps your body's immune system fight off the cancer cells. It's designed to connect your immune cells to cancer cells, helping your body recognise and destroy them.

What does 'low-intensity chemotherapy' mean?

It means the chemotherapy drugs are given at a gentler dose than standard chemotherapy. The aim is to reduce strong side effects while still being effective against the cancer.

Why is this study only for 'older adults'?

Older adults and those with other health conditions sometimes find strong chemotherapy difficult to tolerate. This study aims to find a potentially gentler but still effective treatment option specifically for this group.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one treatment group or another. Often, you and your doctors will know which treatment you are receiving, but sometimes studies are 'blinded' where you won't know. The study team will explain this to you clearly.