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Taking people in DenmarkPhase 2

Tests dapagliflozin to help protect the heart during lymphoma treatment

Tests dapagliflozin against placebo in adults with lymphoma receiving first-line chemotherapy.

Key facts

Who runs it
Aalborg University Hospital
Where
Aalborg, Aarhus N, Herning, Koege, Odense C, and Vejle, DenmarkSee the 6 sites
Registry title
A Randomized, placebo-controlled, double-blinded Phase 2 Trial of Dapagliflozin for Preventing Treatment-associated Cardiotoxicity in Lymphoma
Status
Recruiting
Phase
Phase 2
People taking part
74 people, planned
Started
12 Mar 2026
Expected to end
31 Mar 2030
Type of study
Interventional
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain lymphomas who are about to start first-line (R-)CHOP or (R-)CHOEP chemotherapy. It tests whether dapagliflozin protects the heart during treatment.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Diffuse large B-cell lymphoma and other large B-cell lymphomas, mediastinal B-cell lymphomas, follicular lymphoma grade 1-3a and 3b, ALK-positive anaplastic large T-cell lymphoma, T-cell lymphomas not planned for stem cell transplantation in first line, or transformed lymphoma from indolent lymphoma/CLL.
Earlier treatment
Planned for 6 cycles of full standard dose (R-)CHOP or (R-)CHOEP. Planned high-dose therapy with autologous stem cell transplantation is not allowed.
Biomarker or test result
Baseline ejection fraction of 50% or more and GLS of -16 or lower (as written: GLS ≥ - 16).

Main reasons for not taking part

  • Diabetes (type 1 or type 2)
  • Ongoing treatment with SGLT2 inhibitors, or past intolerance
  • Kidney disease with eGFR below 45 ml/min or creatinine above 2x the upper normal value
  • Atrial fibrillation or atrial flutter
  • Alcohol abuse or any drug abuse

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Diffuse large B-cell lymphoma (all subtypes), any type of large B-cell lymphomas, mediastinal B-cell lymphomas (including PMBL and grey zone lymphomas), follicular lymphoma Grade 3b, anaplastic large T-cell lymphoma (ALK positive), follicular lymphoma grade 1-3a, T-cell lymphomas not planned for stem cell transplantation in first line, or transformed lymphoma from any type of indolent lymphoma/CLL
  • Planned for 6 cycles of full standard dose (R-)CHOP or (R-)CHOEP
  • Baseline ejection fraction ≥50% and GLS ≥ - 16
  • Age ≥18 and ≤ 80 years
  • Written informed consent
  • Capable of reading and understanding the Danish language
  • Safe contraception for both men and women when relevant as described in detail in section 13
  • Willingness to comply with protocol specified procedures; the investigator believes that the subject understands what the study entails, is capable of following instructions, can attend when needed, and is expected to complete the study

Who cannot take part

  • Ongoing treatment with SGLT2 inhibitors or prior intolerability
  • Ongoing treatment with angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ACEi/ARB; patients can be included if ACEi/ARB are discontinued at inclusion)
  • Planned consolidation therapy with high-dose therapy and autologous stem cell transplantation
  • Lithium therapy
  • Planned radiotherapy against mediastinal bulk
  • Alcohol abuse (defined as >4 standard drinks/day and >10 standard drinks/week) or any drug abuse
  • Ongoing statin therapy (patients can be included if it is considered safe to discontinue statins during the study)
  • Severe liver disease hindering full standard dose (R-)CHOP or (R-)CHOEP
  • Allergy to study drug ingredients
  • Diabetes (type 1 or type 2)
  • Any significant heart diseases precluding full-dose anthracycline therapy based on investigator assessment
  • Kidney disease with eGFR <45 ml/min or creatinine > 2x upper normal value
  • Ongoing use of mineralocorticoid receptor antagonist (MRA); patients can be included if it is considered safe to discontinue MRA during the study
  • Use of loop diuretics at a total daily dose exceeding 80 mg furosemide (or equivalent); patients can be included if it is safe to reduce the daily dose to a maximum of 80 mg furosemide (or equivalent) during the study treatment
  • Atrial fibrillation or atrial flutter

Where in Denmark

  • Aalborg University HospitalAalborg, DenmarkTaking people
  • Region MidtjyllandAarhus N, DenmarkTaking people
  • Region MidtjyllandHerning, DenmarkTaking people
  • Region SjaellandKoege, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people
  • Lillebaelt HospitalVejle, DenmarkTaking people

About the trial

What the trial wants to find out

The primary objective of this study is to investigate the cardioprotective effects of an SGLT2 inhibitor administered to patients with lymphoma during first line treatment with (R-)CHO(E)P.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Randomized, placebo-controlled, double-blinded Phase 2 Trial of Dapagliflozin for Preventing Treatment-associated Cardiotoxicity in Lymphoma
Plain-language title
Tests dapagliflozin to help protect the heart during lymphoma treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
6 November 2026