2025-524810-28-00招募中3 期
A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia
Quetzal Therapeutics LLC67 个研究点 分布在 6 个国家目标入组 89 人开始时间: 2026年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 89
- 试验地点
- 67
- 主要终点
- PK parameters, including maximum plasma concentration (Cmax) and area under curve (AUC) for all metabolites of arsenic trioxide, including arsenious acid (AsIII), arsenic acid (ASV), total arsenic, dimethylarsinic acid (DMA), and monomethylarsenic acid (MMA).
研究概览
简要总结
To characterize the PK of QTX-2101 To characterize the treatment response of QTX2101/ATRA at the end of Consolidation Cycle 3
研究设计
- 分配方式
- Na
- 主要目的
- Safety Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥18 to <71 years old at the time of signing an informed consent.
- •Participants must be capable of giving signed and dated institutional review board or independent ethics committee approved informed consent.
- •Participants must have a diagnosis of APL characterized by the presence of the t(15;17) translocation by fluorescence in situ hybridization or cytogenetics, or PML/RARA gene expression via RT-qPCR.
- •Participants must be classified as low- or intermediate-risk APL, defined as WBC count ≤10×109/L at diagnosis.
- •PART 1 Only: Participants with LR-APL should have completed induction and 3 cycles of Consolidation treatment with IV ATO and ATRA. They should have documented mCR at the time of study entry.
- •PART 2 Only: Participants should be ND LR-APL.
- •Participants must have organ function as defined below: • Serum total bilirubin ≤3.0 mg/dL • Alanine aminotransferase and Aspartate aminotransferase ≤3× upper limit of normal • Creatinine clearance ≥30 mL/min
- •Participants must have an Eastern Cooperative Oncology Group Performance Status of ≤
- •Participants must have a serum or high-sensitivity urine pregnancy test (for females of childbearing potential) that is negative at the Screening Visit and immediately prior to initiation of treatment (first dose of study intervention).
- •Participants must be willing and able to comply with the scheduled study visits, treatment plans, including receipt of study intervention at the study site through the end of study period, laboratory tests, contraception guidance, and other procedures. Note: Participants must be willing and able to provide written informed consent and commit to complete the full treatment and follow-up procedures as outlined in the protocol, unless discontinuation is medically indicated or required by the investigator or sponsor.
排除标准
- •Participants who have had treatment for APL with ATRA for >7 days prior to the first dose of study intervention (Part 2 only).
- •Participants with a history of other cancers must not be receiving active treatment (with radiation or chemotherapy) and must be free of disease for 2 years prior to the Screening Visit with the exception of localized prostate cancer treated with hormone monotherapy, breast cancer treated with hormone monotherapy, basal cell carcinoma, nonmelanoma skin cancer, or cervical carcinoma in situ.
- •Participants with an active, life-threatening, or clinically important uncontrolled systemic infection requiring hospitalization.
- •Participants who have a known malabsorption syndrome or other condition that may impair absorption of study medication (eg, gastrectomy) or who are unable to swallow oral medication.
- •Participants who have other severe acute or chronic medical conditions (and/or psychiatric conditions or laboratory abnormalities) that may increase the expected risk to the participant (ie, the risk associated with the study participation or study intervention administration) or that may interfere with the interpretation of study results or, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Immunocompromised participants with increased risk of opportunistic infections, including known human immunodeficiency virus (HIV)-positive participants with CD4 counts ≤350 cells/mm3 or history of opportunistic infection in the last 12 months. To ensure that effective antiretroviral therapy, when used in eligible HIV-positive participants, is tolerated and that toxicities are not confusing with investigational drug toxicities, participants should be on an established antiretroviral therapy for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to the Screening Visit.
- •Participants who have a known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. Participants with a history of HCV infection who have completed curative therapy for HCV at least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for randomization.
- •Participants with indications requiring uninterrupted anticoagulation (eg, mechanical heart valves) due to increased risk of hemorrhagic complications during induction (Part 2).
- •Pregnant females, breastfeeding females, and males not willing to comply with contraceptive requirements or females of childbearing potential not willing to comply with contraceptive requirements.
- •Participants who are likely to withdraw consent at the completion of treatment, or during study follow-up, for the sole purpose of enrolling in another interventional clinical study for APL or another investigational therapy, unless recommended by the investigator or sponsor.
- •Participants who have suspected central nervous system involvement with leukemia.
- •Participants with Grade ≥2 neuropathy.
- •Participants with a history of torsade de pointes.
- •Participants with ECG abnormalities, including: • Congenital long QT syndrome. • History or presence of significant ventricular or atrial tachyarrhythmia. • Clinically significant resting bradycardia (<50 beats per minute). • Corrected QT interval (QTc) >450 msec on screening ECG using QTcF, obtained as the mean from 3 QTcF values from a triplicate standard resting ECG at screening. • Right bundle branch block plus left anterior hemiblock, bifascicular block.
- •Participants with unresolved related AEs from prior exposure of IV ATO (Part 1 only) unless the AEs are Grade 1 or completely resolved prior to enrollment.
- •Participants with a current or recent (within 3 months prior to the Screening Visit) history of symptomatic congestive heart failure.
- •Participants who have a known contraindication or hypersensitivity to ATO, ATRA, or any of their excipients, including participants with hypersensitivity to soy and/or peanut (ATRA).
- •Participants who received any other investigational agents within 30 days of the Screening Visit or <5 half-lives since completion of previous investigational therapy, whichever is shorter.
研究组 & 干预措施
QTX-2101
Test
干预措施: QTX-2101 (Drug)
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Comparator
干预措施: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion (Drug)
结局指标
主要结局
PK parameters, including maximum plasma concentration (Cmax) and area under curve (AUC) for all metabolites of arsenic trioxide, including arsenious acid (AsIII), arsenic acid (ASV), total arsenic, dimethylarsinic acid (DMA), and monomethylarsenic acid (MMA).
PK parameters, including maximum plasma concentration (Cmax) and area under curve (AUC) for all metabolites of arsenic trioxide, including arsenious acid (AsIII), arsenic acid (ASV), total arsenic, dimethylarsinic acid (DMA), and monomethylarsenic acid (MMA).
Molecular complete remission (mCR) defined as absence of promyelocytic leukemia/ retinoic acid receptor alpha (PML/RARA) in the bone marrow per European Leukemia Net (ELN) 2019 criteria for APL. Negativity of PML/RARA is defined as PML/RARA transcript level below 10-4, confirmed by centralized quantitative reverse transcription-polymerase chain reaction (RTqPCR) testing using an assay with a limit of detection (LOD) of 10-5.
Molecular complete remission (mCR) defined as absence of promyelocytic leukemia/ retinoic acid receptor alpha (PML/RARA) in the bone marrow per European Leukemia Net (ELN) 2019 criteria for APL. Negativity of PML/RARA is defined as PML/RARA transcript level below 10-4, confirmed by centralized quantitative reverse transcription-polymerase chain reaction (RTqPCR) testing using an assay with a limit of detection (LOD) of 10-5.
次要结局
- Incidence of adverse events (AEs), clinically significant laboratory changes, significant electrocardiogram (ECG) findings, and vital sign changes.
- Landmark EFS at the time of the primary endpoint analysis, defined as time from randomization to the date of induction treatment failure (failure to achieve complete remission [CR]/morphologic complete remission [CRi] after induction), no achievement of mCR after 3 consolidation courses, relapse after CR/mCR, or death from any cause, whichever comes first.
- Other parameters of efficacy, including CR/CRi rate, defined as achieving CR/CRi at the end of induction and end of Consolidation Cycle 3 per ELN 2019 criteria for APL and landmark overall survival (OS), defined as duration from randomization to date of death due to any cause
- Incidences of AEs, clinically significant laboratory changes, significant ECG, and vital sign changes
- Summary statistics of QTX-2101 steady-state AUC and Cmax, determined by population PK analysis.
- Triplicate ECGs with time-matched PK sampling analysis.
- Participant-reported outcomes assessing quality of life (eg, EORTC QLQ-C30), treatment convenience and satisfaction (eg, CCSQ), health utility (eg, EQ-5D-5L), and overall treatment burden (eg, number of infusion visits, catheter use, and time in treatment)
研究者
Shaad Abedin, MD FACP
Scientific
Quetzal Therapeutics LLC
研究点 (67)
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