2025-521205-41-00招募中2 期
A Randomized, placebo-controlled, double-blinded Phase 2 Trial of Dapagliflozin for Preventing Treatment-associated Cardiotoxicity in Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
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.
次要结局
- 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′.
- Change in right ventricle related parameters including TAPSE and TRmax
- LVEF change assessed using WMI and Simpson biplane in addition to change in cardiac output assessed using VTI.
- Change in serum values of troponin T or I and N-Terminal pro-B-type natriuretic peptide (NT-proBNP) or proBNP.
- ECG findings and changes in relation to echocardiographic measurements and rate of heart failure
- Rate of heart failure in the placebo and SGLT2 inhibitor arm
- 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
- Cardiopulmonary symptoms during follow-up using New York Heart Association (NYHA).
- Tolerability of SGLT2 inhibitors administered in combination with R-CHOP, assessed using descriptive summaries of CTCAE reportings and dose reductions/interruptions/discontinuations
研究者
Kristian Hay Kragholm
Scientific
Aalborg University Hospital
研究点 (5)
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