Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy

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What is this study about?

This study focuses on patients with different types of lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and T-cell lymphomas. The research examines whether a medication called dapagliflozin can protect the heart from potential damage during standard cancer treatment. Dapagliflozin belongs to a group of medications known as SGLT2 inhibitors, which are typically used to treat diabetes.

The study will test if taking dapagliflozin while receiving standard lymphoma treatment can help prevent heart-related side effects. Participants will receive either dapagliflozin or placebo tablets for 6 months while undergoing their regular cancer treatment. The medication or placebo will be taken by mouth once daily.

During the study, doctors will monitor heart function using various tests to measure how well the heart is working. These tests include examining heart muscle movement, blood flow patterns, and checking certain substances in the blood that can indicate heart health. The study will also track any heart-related symptoms that participants may experience during their treatment.

1 Initial treatment preparation

You will be assigned randomly to receive either dapagliflozin or placebo (an inactive substance) through oral administration

Your heart function will be measured to confirm that your heart’s ejection fraction is at least 50%

Basic medical tests will be performed to ensure you meet the study requirements

2 Main treatment phase

You will receive 6 cycles of standard lymphoma treatment called (R-)CHOP or (R-)CHOEP

Throughout this period, you will take either dapagliflozin or placebo orally as prescribed

Regular heart monitoring will be conducted using various tests including heart scans

3 One-month follow-up

One month after completing treatment, you will undergo a detailed heart examination

The examination will measure the heart’s ability to pump blood effectively

Various heart-related measurements will be taken, including heart muscle strain and blood tests

4 Ongoing monitoring

Regular heart examinations will continue to monitor your heart function

Tests will include heart scans, blood tests for heart markers, and electrocardiograms (ECG)

Your breathing and physical capacity will be evaluated using a standardized assessment

Computer tomography (CT) scans will be performed as scheduled to examine heart-related changes

Who Can Join the Study?

Diagnosed with one of these blood cancers: diffuse large B-cell lymphoma, follicular lymphoma, or T-cell lymphoma that does not require stem cell transplantation as first treatment
Planning to receive 6 cycles of standard chemotherapy treatment called (R-)CHOP or (R-)CHOEP (medications used to treat lymphoma)
Have a heart function test showing an ejection fraction of 50% or higher (a measure of how well your heart pumps blood)
Age between 18 and 80 years old
Able to give written permission to participate in the study
Able to read and understand Danish language
Willing to use effective birth control methods (both men and women when applicable)
Able to understand study requirements and follow instructions
Able to attend all required study visits and complete the study as planned

Who Cannot Join the Study?

Age below 18 years old or above 75 years old
Having type 1 diabetes (a condition where the body does not produce insulin)
History of diabetic ketoacidosis (a serious complication of diabetes with high blood sugar levels)
Severe kidney disease with eGFR below 30 mL/min (reduced kidney function)
Currently pregnant or breastfeeding
Known allergies to SGLT2 inhibitors (the study medication)
Active or recent serious infections
Severe heart problems including uncontrolled heart failure
History of frequent urinary tract infections
Currently taking medications that may interact with SGLT2 inhibitors
Unable to provide informed consent
Participation in another clinical trial within the last 30 days
History of poor compliance with medical treatments
Having conditions that could interfere with study participation or evaluation
Having hypotension (abnormally low blood pressure)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Region Sjaelland	Holbæk	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2025

Trial locations

Investigated drugs:

Placebo

Dapagliflozin is a medication that belongs to a group called SGLT2 inhibitors. It works by helping the kidneys remove sugar from the blood through urine. In this trial, it is being studied for its potential protective effects on the heart during cancer treatment. The medication is already approved for treating diabetes, but researchers are investigating if it can help prevent heart problems that sometimes occur during lymphoma therapy.

R-CHOP or R-CHOEP is a combination of chemotherapy medications commonly used to treat lymphoma (a type of blood cancer). This is the standard treatment that patients receive for lymphoma, and it includes several different medications given together. While effective against cancer, these medications can sometimes affect heart function, which is why researchers are studying ways to protect the heart during treatment.

Investigated diseases:

Diffuse large B-cell lymphoma – A fast-growing cancer that affects white blood cells called B lymphocytes. It develops in the lymph nodes and can spread to other parts of the body. The disease causes enlarged lymph nodes and may affect organs like the spleen, liver, or bone marrow.

Follicular lymphoma Grade 3b – A type of blood cancer that begins in the lymphatic system, specifically affecting B lymphocytes. It is characterized by a specific pattern of growth in lymph nodes. Grade 3b indicates a more aggressive form of the disease.

Anaplastic large T-cell lymphoma (ALK positive) – A rare type of lymphoma that develops from T-cells carrying a specific protein marker called ALK. The disease typically affects lymph nodes and can involve skin, bones, and other organs.

Follicular lymphoma grade 1-3a – A slow-growing blood cancer that develops from B lymphocytes in the lymphatic system. The grading indicates how the cells look under microscope, with grades 1-3a representing different levels of cell appearance changes. It primarily affects lymph nodes.

T-cell lymphomas – A group of blood cancers that develop from T lymphocytes. These lymphomas can occur in various parts of the body, affecting lymph nodes and other organs. The disease causes abnormal growth and function of T-cells in the immune system.

Trial ID:

2025-521205-41-00

Protocol code:

DACALY

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?