2024-511627-34-00招募中2 期
Daratumumab in adults with Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) Treated According to the ALL National Treatment Program (DARATALL-VHR)- GIMEMA ALL3024
Fondazione Gimema Franco Mandelli Onlus23 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年7月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 23
- 主要终点
- The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity (<10^-4) after induction (TP1) - in patients with very high-risk T-ALL treated with a daratumumab plus chemotherapy approach.
研究概览
简要总结
The primary objective of the trial is to evaluate the impact of the addition of daratumumab to the national standard of care, based on the pediatric-inspired treatment (i.e. LAL1913) in increasing the MRD-negativity rate (<10-4) at time point 1 (TP1), i.e. after the first induction cycle with chemotherapy plus daratumumab, in very high-risk T-ALL.
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
- •Age 18-65 years.
- •Signed written informed consent according to ICH/E U/GCP and national local laws.
- •A diagnosis of T-ALL according to the 2022 International Consensus Classification (ICC) is required, either de novo or secondary to chemo-radiotherapy for another cancer. Pre-treatment with low-dose corticosteroids +/- cyclophosphamide in patients presenting with hyperleukocytosis is allowed.
- •Availability of fresh bone marrow (BM) (or peripheral blood (PB) in patients with hyperleukocytosis) samples to perform diagnostic procedures).
- •Bone marrow blast percentage at diagnosis ≥20%.
- •CD38 positivity on ALL blasts (any level of positivity).
- •ETP and near ETP at diagnosis according to internationally accepted criteria (appendix G) at diagnosis or other VHR T-ALL subtypes (WBC count >100 x109/L; complex karyotype with ≥5 unrelated anomalies; other CD1a-negative immunophenotypes). T-Myeloid MPAL according to the 2022 ICC of Acute Leukemias of Ambiguous Lineage (appendix H) can also be eligible and considered as VHR.
- •Availability of full cytological, cytochemical, immunophenotypic, cytogenetic and molecular disease characterization according to the EGIL and WHO classifications.
- •An ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself, (and not by pre-existing comorbidities,) and is considered and/or documented to be reversible following the application of anti-leukemic therapy and appropriate supportive measures.
- •For females of childbearing potential, a negative pregnancy test must be documented. Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 12 months after the end of treatment.
排除标准
- •Diagnosis of B-lineage ALL, and Ph+ ALL.
- •Down’s syndrome.
- •Prior systemic chemotherapy for ALL (excluding cyclophosphamide during pre-phase).
- •Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), FE<50% (unless attributable to ALL), severe liver disease with serum direct bilirubin >3 mg/dL (unless attributable to Gilbert’ syndrome or ALL) and/or ALT >5x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL), severe lung disease with FEV1<50% (unless attributable to ALL) and severe neuropsychiatric disorder that impairs the patient’s ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
- •Presence of serious, active, uncontrolled infections.
- •A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with a life expectancy <2 years.
- •Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- •Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs. prior treatment start). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ two effective reliable methods of birth control throughout the study and for up to 12 months following discontinuation of study drugs.
结局指标
主要结局
The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity (<10^-4) after induction (TP1) - in patients with very high-risk T-ALL treated with a daratumumab plus chemotherapy approach.
The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity (<10^-4) after induction (TP1) - in patients with very high-risk T-ALL treated with a daratumumab plus chemotherapy approach.
次要结局
- CIR estimation from CR achievement at 18 months
- OS at 18 months
- Treatment-related mortality (TRM)
- The rate of MRD negativity at TP2, TP3, TP4 and before allo-SCT
- The rate of allo-SCT allocation
- DFS at 12 months
- EFS at 18 months
- Rate of Adverse Events (AEs) and Serious AEs
研究者
Data center
Scientific
Fondazione Gimema Franco Mandelli Onlus
研究点 (23)
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