DAPAGLIFLOZIN PROPANEDIOL for Diffuse large B-cell lymphoma | Follicular lymphoma | Anaplastic large-cell lymphoma (ALK positive) | T-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Diffuse large B-cell lymphoma NOS, follicular lymphoma Grade 3b, anaplastic large T-cell lymphoma (ALK positive), follicular lymphoma grade 1-3a, and T-cell lymphomas not planned for stem cell transplantation in first line\n- Planned for 6 cycles of full standard dose (R-)CHOP or (R-)CHOEP\n- Baseline ejection fraction ≥50% (GLS ≥ - 16)\n- Age ≥18 and ≤ 80 years\n- Written informed consent\n- Capable of reading and understanding the Danish language\n- Safe contraception for both men and women when relevant as described in detail in section 13\n- 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 criteria

• {"criterion_text":"- Ongoing treatment with SGLT2 inhibitors or prior intolerability\n- Lithium therapy\n- Planned radiotherapy against mediastinal bulk\n- Alcohol abuse (defined as >4 standard drinks/day and >10 standard drinks/week) or any drug abuse\n- Allergy to study drug ingredients\n- Diabetes (type 1 or type 2)\n- Any significant heart diseases precluding full-dose anthracycline therapy based on investigator assessment\n- Atrial fibrillation or atrial flutter\n- Ongoing statin therapy\n- Ongoing treatment with angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ACEi/ARB)\n- Kidney disease with eGFR <60 ml/min or creatinine > 2x upper normal value\n- Severe liver disease hindering full standard dose (R-)CHOP or (R-)CHOEP\n- Daily use of loop-diuretic therapy"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the change in global longitudinal strain between baseline and first month after end of treatment, where we define a ≥10% reduction as significant and indicative of cardiotoxicity in agreement with previous published studies.","definition_or_measurement_approach":"Change in global longitudinal strain (GLS) measured from baseline to one month after end of treatment; a ≥10% reduction in GLS is defined as significant and indicative of cardiotoxicity."}

Secondary endpoints

• {"endpoint_text":"- Diastolic parameter changes including the mitral valve filling pattern assessed by Doppler velocity measurements, the E/A ratio representing the early wave velocity (E) to the late velocity after atrial contraction (A), the deceleration time of the E wave, the early and late velocities of the mitral annulus measured by tissue Doppler (e′ and a′), isovolumetric relaxation time (IVRT), the left atrial volume, and the derived E/ e′.","definition_or_measurement_approach":"Echocardiographic diastolic parameters measured by Doppler and tissue Doppler (E/A, deceleration time, e′, a′, IVRT, left atrial volume, E/e′)."}
• {"endpoint_text":"- Change in right ventricle related parameters including TAPSE and TRmax","definition_or_measurement_approach":"Right ventricular function measures including TAPSE and TRmax assessed by echocardiography."}
• {"endpoint_text":"- LVEF change assessed using WMI and Simpson biplane in addition to change in cardiac output assessed using VTI.","definition_or_measurement_approach":"Left ventricular ejection fraction assessed by Wall Motion Index (WMI) and Simpson biplane; cardiac output assessed using velocity time integral (VTI)."}
• {"endpoint_text":"- Change in serum values of troponin T or I and N-Terminal pro-B-type natriuretic peptide (NT-proBNP) or proBNP.","definition_or_measurement_approach":"Biomarker changes measured in serum: troponin T or I and NT-proBNP/proBNP."}
• {"endpoint_text":"- ECG findings and changes in relation to echocardiographic measurements and rate of heart failure","definition_or_measurement_approach":"ECG changes correlated with echocardiographic measurements and clinical heart failure events."}
• {"endpoint_text":"- Rate of heart failure in the placebo and SGLT2 inhibitor arm","definition_or_measurement_approach":"Incidence/rate of heart failure events compared between placebo and SGLT2 inhibitor arms."}
• {"endpoint_text":"- Coronary artery calcium score in pre-planned, interim and end of treatment computer tomography (CT) scans in relation to ischemic heart disease and heart failure","definition_or_measurement_approach":"Coronary artery calcium score measured on planned CT scans at pre-planned, interim and end-of-treatment timepoints."}
• {"endpoint_text":"- Cardiopulmonary symptoms during follow-up using New York Heart Association (NYHA).","definition_or_measurement_approach":"Assessment of cardiopulmonary symptoms using NYHA functional classification during follow-up."}
• {"endpoint_text":"- Tolerability of SGLT2 inhibitors administered in combination with R-CHOP, assessed using descriptive summaries of CTCAE reportings and dose reductions/interruptions/discontinuations","definition_or_measurement_approach":"Tolerability assessed by CTCAE adverse event reporting and records of dose reductions, interruptions, and discontinuations."}

Denmark

Earliest CTIS Part Ii Submission Date

08-09-2025

Latest Decision Or Authorization Date

13-02-2026

Processing Time Days

158

Number Of Sites

6

Number Of Participants

74

Primary sponsor

Full Name

Aalborg University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Sygehusapoteket Region Nordjylland","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Hospital/Clinic/Other health care facility"}