A Randomized, placebo-controlled, double-blinded Phase 2 Trial of Dapagliflozin for Preventing Treatment-associated Cardiotoxicity in Lymphoma
Key facts
- Where
- Aalborg, Aarhus N, Herning, Koege, Odense C és Vejle, DániaSee the 6 sites
- Phase
- 2. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaTaking people
- Region MidtjyllandAarhus N, DániaTaking people
- Region MidtjyllandHerning, DániaTaking people
- Region SjaellandKoege, DániaTaking people
- Odense University HospitalOdense C, DániaTaking people
- Lillebaelt HospitalVejle, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University Hospital
- Trial code
- EU 2025-521205-41-00
- Record updated
- 2026. november 6.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.