JPRN-jRCT2011230008招募中3 期
A prospective randomized, double-blind, placebo-controlled, multi-center phase III study to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT) - MO-TRANS
Kueenburg Elisabeth0 个研究点目标入组 30 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2022 classification of AML
- •2. Subjects with European LeukemiaNet (ELN) high-risk AML in CR1, intermediate-risk AML in CR1, or AML of any risk in CR2
- •3. Subjects planned to undergo allogeneic HCT, with all of the following parameters met:
- •- Planned use of fully matched related or unrelated donor or with no more than 1 antigen mismatch at human leukocyte antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor.
- •- Planned use of granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSCs)
- •- Planned use of myeloablative conditioning regimen that is expected to result in donor chimerism of >= 90%
- •- Planned use of CsA-based or TAC-based GvHD prophylaxis
- •4. Life expectancy >= 6 months at screening
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Male or female, age >= 18 years and <= 75 years
- •7. Body weight of >= 50 kg
- •8. Able and willing to provide written informed consent and comply with the trial protocol and procedures
- •9. Contraception for females of childbearing potential and sexually active males
- •10. Affiliation to a national health insurance scheme (only applicable if required by local regulations)
排除标准
- •1. Planned use of anti-thymocyte globulin (ATG), alemtuzumab, sirolimus, abatacept, for GvHD prophylaxis.
- •2. Planned use of serotherapy during conditioning, including ATG and alemtuzumab.
- •3. Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection.
- •4. Subjects having received prior allogeneic HCT or recipients of a solid organ transplant.
- •5. Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible. 6. Major surgery within 4 weeks prior to randomization or a major wound that has not fully healed.
- •7. Require any of the following treatments for cardiac dysfunction:
- •- Treatment with medication that impairs cardiac conduction (e.g. beta blockers, verapamil-type and diltiazem-type calcium channel blockers, or cardiac glycosides)
- •- Treatment with quinidine
- •8. Subjects with acute promyelocytic leukemia.
- •9. Diagnosis of any previous or concomitant malignancy, except subjects diagnosed with localized basal cell carcinoma of the skin or in situ cervical cancer, or subjects who have completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for the malignancy at least 3 years prior to enrollment.
- •10. Blast crisis of chronic myeloid leukemia.
- •11. Concurrent severe and/or uncontrolled medical condition including:
- •- Clinically significant pulmonary fibrosis
- •- Tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive purified protein derivative (PPD) skin reaction
- •- Subjects with any other types of clinically significant obstructive pulmonary disease
- •- Uncontrolled diabetes mellitus as assessed by the investigator or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy
- •- Uncontrolled seizure disorder
- •- Uncontrolled depression or history of suicide attempts/ideation
- •12. Cardiac dysfunction as defined by:
- •- Myocardial infarction within the last 3 months of trial entry
- •- Reduced left ventricular function with an ejection fraction < 40% within 6 weeks before signing informed consent
- •- History or presence of stable or unstable ischemic heart disease (IHD), myocarditis, or cardiomyopathy
- •- New York Heart Association (NYHA) Class II-IV congestive heart failure
- •- Unstable cardiac arrhythmias including history of or presence of symptomatic bradycardia
- •- Resting heart rate (physical exam or 12-lead electrocardiogram (ECG)) < 50 bpm
- •- History or current diagnosis of ECG abnormalities indicating significant risk of safety such as: Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, presence of a clinically relevant impairment of cardiac conduction including sick sinus syndrome, or sino-atrial heart block, clinically significant atrioventricular (AV) block, bundle branch block or resting QTc (Fridericia preferred, but Bazett acceptable) > 450 msec for males and > 470 msec for females at Screening or Baseline ECG
- •- History or presence of symptomatic arrhythmia or arrhythmia requiring treatment or being otherwise of clinical significance
- •- Uncontrolled arterial hypertension; if controlled, the medication must be stable for 3 months prior to baseline visit
- •- Requiring treatment with prohibited medication listed under 'Exclusi
研究者
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