BridgeMD
A Randomized, placebo-controlled, double-blinded Phase 2 Trial of Dapagliflozin for Preventing Treatment-associated Cardiotoxicity in Lymphoma
EU CTIS ID: 2025-521205-41-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Planned for 6 cycles of full standard dose (R-)CHOP or (R-)CHOEP
- Baseline ejection fraction ≥50% (GLS ≥ - 16)
- Age ≥18 and ≤ 80 years
- Written informed consent
- Capable of reading and understanding the Danish language
You likely can't join if
- Ongoing treatment with SGLT2 inhibitors or prior intolerability
- Lithium therapy
- Planned radiotherapy against mediastinal bulk
- Alcohol abuse (defined as >4 standard drinks/day and >10 standard drinks/week) or any drug abuse
- Allergy to study drug ingredients
- Diabetes (type 1 or type 2)
See the full eligibility criteria
- 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
- Planned for 6 cycles of full standard dose (R-)CHOP or (R-)CHOEP
- Baseline ejection fraction ≥50% (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
- Ongoing treatment with SGLT2 inhibitors or prior intolerability
- Lithium therapy
- Planned radiotherapy against mediastinal bulk
- Alcohol abuse (defined as >4 standard drinks/day and >10 standard drinks/week) or any drug abuse
- Allergy to study drug ingredients
- Diabetes (type 1 or type 2)
- Any significant heart diseases precluding full-dose anthracycline therapy based on investigator assessment
- Atrial fibrillation or atrial flutter
- Ongoing statin therapy
- Ongoing treatment with angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ACEi/ARB)
- Kidney disease with eGFR <60 ml/min or creatinine > 2x upper normal value
- Severe liver disease hindering full standard dose (R-)CHOP or (R-)CHOEP
- Daily use of loop-diuretic therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.