A study comparing AZD0486 after reduced chemotherapy versus standard chemotherapy in older or unfit patients with newly diagnosed large B-cell lymphoma

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What is this study about?

This study is looking at large B-cell lymphoma, which is a type of cancer that affects the immune system. The study involves two different treatment approaches. One approach uses a combination of medicines called R-mini-CHOP, which includes rituximab (or similar medicines called Truxima, MabThera, or Ruxience), cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone. This combination is given through a vein or as tablets. The other approach uses R-mini-CHOP for a shorter time followed by a medicine called AZD0486, which is given through a vein. Some participants may also receive additional medicines called pegfilgrastim or tocilizumab if needed.

The purpose of the study is to compare how well these two treatment approaches work and to check their safety in older adults or those who are not strong enough for standard treatment. The study will measure how long participants live without their disease getting worse and will also look at side effects and quality of life. The first part of the study will test the safety of the shorter R-mini-CHOP treatment followed by AZD0486 in a small group of participants to make sure the dose is appropriate.

Participants will be randomly assigned to receive either six cycles of R-mini-CHOP or two cycles of R-mini-CHOP followed by treatment with AZD0486. During the study, participants will have regular check-ups, blood tests, and scans to monitor their disease and overall health. The treatment period can last up to several months, and participants will continue to be followed for several years after treatment ends to see how well the treatment worked over time.

1 Treatment assignment

Upon joining the study, you will be assigned to one of two treatment groups. This assignment will be done randomly, which means it will be determined by chance, similar to flipping a coin.

One group will receive R-mini-CHOP treatment for 2 cycles followed by AZD0486. The other group will receive R-mini-CHOP treatment for 6 cycles.

2 R-mini-CHOP treatment cycles

The R-mini-CHOP treatment consists of a combination of five medications given together. Each treatment cycle will be administered at specific intervals.

Rituximab will be given through a vein as an infusion. This medication helps target specific cells involved in your condition.

Cyclophosphamide will be administered through a vein as an infusion.

Doxorubicin hydrochloride will be given through a vein as an injection or infusion.

Vincristine sulfate will be administered through a vein as an injection.

Prednisone will be taken by mouth as a tablet.

If you are assigned to the first group, you will receive 2 cycles of this combination treatment. If you are assigned to the second group, you will receive 6 cycles of this combination treatment.

3 Supportive medication

During the treatment cycles, you may receive pegfilgrastim as a supportive medication. This is given as an injection under the skin to help your body produce white blood cells.

You may also receive tocilizumab as an infusion through a vein if needed to manage certain side effects.

4 AZD0486 treatment (for selected group only)

If you are assigned to the first treatment group, after completing 2 cycles of R-mini-CHOP, you will begin receiving AZD0486.

AZD0486 is an antibody medication that will be given through a vein as an infusion. The exact dose and schedule will be determined based on safety assessments conducted during the study.

5 Disease monitoring and assessments

Throughout the study, your disease will be monitored using imaging scans to assess how the treatment is working.

Blood samples will be collected at various times to measure medication levels in your body and to check for any immune responses to the treatment.

Your vital signs and laboratory tests will be checked regularly to monitor your overall health and detect any changes.

6 Safety monitoring

Your health will be closely monitored for any side effects or adverse events throughout the study.

Any side effects, whether mild or serious, will be recorded and assessed by the study team.

If you experience side effects, adjustments to your treatment may be made, or treatment may be temporarily stopped or discontinued if necessary.

7 Quality of life assessments

You will be asked to complete questionnaires about your symptoms, including pain and tiredness, at different times during the study.

These questionnaires will also ask about any side effects you may be experiencing and how they affect your daily life.

You will provide information about your overall quality of life and any concerns specific to your condition.

8 Follow-up period

After completing the assigned treatment, you will continue to be monitored for an extended period.

Follow-up assessments will track the status of your disease and your overall survival.

Information about any disease progression or need for additional treatment will be collected during this time.

Who Can Join the Study?

To join this clinical trial, patients must meet the following requirements:

You must be at least 80 years old, OR you must be between 65 and 79 years old and considered unfit based on a simplified geriatric assessment, which is a health evaluation for older adults that checks physical and mental abilities, and your doctor believes you are not suitable for full-dose R-CHOP, which is a standard combination of chemotherapy medicines.
You must have a confirmed diagnosis of Large B-cell Lymphoma, which is a type of cancer affecting white blood cells, that has never been treated before. The diagnosis must be confirmed by examining tissue samples under a microscope according to the World Health Organization classification. This does not include a specific subtype called plasmablastic lymphoma or follicular large cell lymphoma.
Your disease must be visible on a special imaging scan called FDG-PET, which uses a radioactive sugar to detect cancer cells, and the cancer must be measurable according to specific medical guidelines called Lugano and Ann Arbor staging, which are systems used to describe how far the cancer has spread.
Your cancer must be classified as Stage I bulky, meaning a single area with a tumor measuring 7.5 centimeters or larger, or anywhere from Stage II to Stage IV, which means the cancer has spread to multiple areas of the body.
You must have an ECOG performance status of 0 to 2, which is a scale that measures how the disease affects your daily living abilities. A score of 0 means you are fully active, 1 means you have some restrictions, and 2 means you can care for yourself but cannot work.
Your bone marrow, which produces blood cells, and your liver, kidneys, and heart must be working well enough based on laboratory tests and medical examinations.
There may be additional requirements that your doctor will discuss with you.

Who Cannot Join the Study?

The source data does not contain specific exclusion criteria information for this clinical trial
Exclusion criteria are reasons why someone cannot join a study, such as having certain other health conditions, taking specific medications, or having test results that fall outside required ranges
Without the detailed exclusion criteria list from the study protocol, it is not possible to provide the specific reasons why a patient might not be able to participate in this particular trial

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Gasthuiszusters Antwerpen	Antwerp	Belgium
Pratia S.A.	Skorzewo	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Cwbxwreez Ullfeqtpychgev Snohktfya	Woluwe-Saint-Lambert	Belgium
Wsyuxnhdula Wchhljrnurywtsckhvxt Cngyxtd Ojykqpvut I Tfhuaqgwkayhj Iz Mculnwbevpn W Lzanb	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.11.2025
Poland	Recruiting	30.11.2025

Trial locations

Investigated drugs:

R-mini-CHOP is a combination of several cancer medicines given together to treat a type of cancer called large B-cell lymphoma. This treatment includes rituximab (a medicine that targets cancer cells) along with other chemotherapy drugs that work together to kill cancer cells. It is given through a vein in reduced doses that are better tolerated by older or less fit patients.

AZD0486 is an investigational medicine being studied in this trial. It is given after the initial treatment with R-mini-CHOP to see if it can help control the cancer better than continuing with more cycles of R-mini-CHOP alone.

Investigated diseases:

B-cell lymphoma

Large B-cell Lymphoma – Large B-cell lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system. It develops when B-cells, a type of white blood cell that normally helps fight infections, grow abnormally and multiply out of control. These cancerous cells typically form tumors in lymph nodes, but can also appear in other organs throughout the body. The disease usually progresses relatively quickly compared to other types of lymphoma. Common signs include swollen lymph nodes, fever, night sweats, unexplained weight loss, and fatigue. As the disease advances, the growing tumors can interfere with normal organ function and weaken the immune system.

Trial ID:

2025-522029-37-00

Protocol code:

D7402C00001

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study comparing AZD0486 after reduced chemotherapy versus standard chemotherapy in older or unfit patients with newly diagnosed large B-cell lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?