Active not recruitingPHASE2INTERVENTIONAL

A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC)

This research study, called ALL-RIC, is for adults aged 40-70 with a type of blood cancer called acute lymphoblastic leukaemia (ALL) who are in remission. It compares two different treatment plans given before a stem cell transplant. The main goal is to see if a slightly stronger treatment plan, which includes a type of radiation called Total Body Irradiation (TBI), can help prevent the leukaemia from returning (relapsing) while keeping the transplant safe. Patients will be randomly assigned to one of the two treatment plans. Researchers will then compare how well each plan works, looking at things like how many patients are still cancer-free after two years and any side effects. This study hopes to improve transplant outcomes for ALL patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Birmingham

Enrolment target

242

Start

22 Nov 2018

Estimated completion

22 Nov 2027

Acute Lymphoblastic Leukemia

What is this study about?

This study is looking at adults who have acute lymphoblastic leukaemia (ALL), a type of blood cancer. These patients have already had treatment and their leukaemia is currently in remission, meaning there are no signs of the cancer. The next step for many of these patients is a stem cell transplant, which can offer them a better chance of staying cancer-free. Before a stem cell transplant, patients usually receive a special type of chemotherapy to prepare their body. This study wants to find the best way to do that.

The study compares two slightly different preparation plans given before the stem cell transplant. One plan uses a combination of medicines called fludarabine and melphalan. The other plan uses cyclophosphamide along with a treatment called Total Body Irradiation (TBI). TBI is a type of radiation that targets cancer cells throughout the body. The main aim is to see if the second plan, with TBI, can do a better job at getting rid of any remaining leukaemia cells that might be too small to detect. The hope is that this will reduce the chance of the leukaemia coming back after the transplant, without making the transplant itself more risky for the patient.

About 242 patients will take part and be randomly put into one of the two treatment groups. This is like flipping a coin to decide which group you are in, and it ensures the comparison is fair. The doctors will follow patients for at least three years to see how well each treatment works, how many patients stay cancer-free, and if there are any side effects. They will also look at other ways to reduce the chance of the cancer coming back, like giving donor white blood cells earlier after the transplant. This research is important because it could help improve the long-term success of stem cell transplants for adults with ALL.

Key takeaways

Compares two pre-transplant treatments for ALL in adults.
Aims to reduce leukaemia returning (relapse).
One treatment includes Total Body Irradiation (TBI).
Patients are randomly assigned to a treatment group.
Follow-up for at least three years to assess outcomes.

Who may be eligible?

This study is looking for adults aged between 40 and 70 years old who have acute lymphoblastic leukaemia (ALL). You need to be in what doctors call 'complete remission', meaning your leukaemia is not currently active, either for the first time or after it came back once and was treated again. You also need to have a suitable donor for a stem cell transplant.

To join, you must be in good enough general health to have a stem cell transplant, as decided by your doctor. This includes having healthy enough liver, kidney, heart, and lung function. Any side effects from your previous cancer treatments should have mostly settled down. If you need it, you must be willing to use effective contraception during and for 12 months after the transplant. Also, you must be able to attend all the hospital visits and tests planned for the study.

You cannot join if you are pregnant or breastfeeding, or if your doctor believes a reduced-intensity stem cell transplant would be too risky for you. If you are female and could become pregnant, you'll need a negative pregnancy test before starting treatment.

Quick self-check

Are you between 40 and 70 years old?
Do you have acute lymphoblastic leukaemia (ALL) that is currently in remission?
Do you have a suitable stem cell donor?
Are you generally healthy enough for a stem cell transplant, as your doctor advises?
Are you able to attend all planned hospital visits and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll first have to confirm you meet all the health requirements. Once that's done, you'll be randomly assigned to one of two treatment groups, like drawing a name out of a hat. You'll then receive one of the two conditioning treatments (either chemotherapy drugs like fludarabine and melphalan, or cyclophosphamide with Total Body Irradiation) before your stem cell transplant.

After your transplant, you'll have regular check-ups and tests, which will include blood tests and possibly other scans or samples to monitor your health and see how well the transplant is working. The aim is to follow you for at least 3 years to see the long-term effects of the treatment and identify if the leukaemia returns. This will involve scheduled visits to the hospital.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of a potentially more effective treatment to prevent your leukaemia from returning, compared to the standard approach. However, all medical treatments carry risks. The treatments involved in this study, especially the Total Body Irradiation, can have side effects. Your care team will explain these in detail so you understand them fully. You are free to withdraw from the study at any time, for any reason, without it affecting the quality of your future medical care.

Locations (22)

Heart of England Nhs Foundation Trust
Birmingham, United Kingdom
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol Nhs Foundation Trust
Bristol, United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
University Hospitals of Leicester Nhs Trust
Leicester, United Kingdom
The Clatterbridge Cancer Centre Nhs Foundation Trust
Liverpool, United Kingdom
Barts Health Nhs Trust
London, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, United Kingdom
Kings College Hospital
London, United Kingdom

+10 more sites — see the official record for the full list.

Common questions

What is the main purpose of this study?

To see if a slightly stronger pre-transplant treatment can better stop leukaemia from coming back in adults, without causing more problems.

What is Total Body Irradiation (TBI)?

TBI is a type of radiation treatment that targets cancer cells throughout your body before a stem cell transplant.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups, like flipping a coin, to ensure a fair comparison.

How long will I be followed in this study?

You will be followed up for at least three years after your stem cell transplant.

Can I leave the study at any time?

Yes, you can leave the study at any point, and your decision won't affect your future medical care.