JPRN-jRCTs041210040招募中3 期
A multicenter phase III study in children, adolescent and young adult, and adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia - JPLSG-ALL-B19
Katsuyoshi Koh0 个研究点目标入组 2,000 人开始时间: 2021年7月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
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
- >= 1age old 至 < 65age old（—）
- 性别
- All
入选标准
- •(1) Diagnosis of B cell precursor ALL or pre-B-ALL
- •(2) Consent to FCM and fusion-gene screening
- •(3) Age >=1 year and < 65 years old at diagnosis
- •(4) ECOG performance status (PS) score of 0-2. However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
- •(5) Sufficient organ function satisfying the laboratory data listed below;
- •-Direct bilirubin <=2.0 mg/dL or within 3x of age-adjusted upper-limit of normal range if the patient is under 16-year-old
- •-Creatinine <=2.0 mg/dL or within 3x of age-adjusted upper-limit of normal range if the patient is under 16-year-old
- •-Normal ECG and UCG
- •-SpO2 >= 94% in room air
- •(6) Written informed consent obtained from patient or guardians.
排除标准
- •(1)BCR-ABL1 positive ALL
- •(2)Down syndrome
- •(3)Malignant hypertension
- •(4)Pulmonary fibrosis
- •(5)Interstitial pneumonia
- •(6)Liver cirrhosis
- •(7)Positive anti-HIV antibody or HBs antigen
- •(8)Uncontrolled diabetes
- •(9)Uncontrolled infection
- •(10)Deep thrombosis requiring treatment.
- •(11)Mental disorder that will likely make it impossible to complete treatment according to the protocol
- •(12)Active double cancer
- •(13)Pregnant or lactating woman, or high possibility of pregnancy
- •(14)Past History of congenital or acquired immunodeficiency
- •(15)Any inappropriate status judged by the physician
研究者
相似试验
进行中（未招募）
不适用
Antibody Persistence in Healthy South African Children After Primary Series and Booster Vaccination with an Investigational(DTaP-IPV-Hep B-PRP-T) or Control VaccinesPrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infections caused by hepatitis B virusMedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-004450-26-Outside-EU/EEASanofi Pasteur SA567
进行中（未招募）
不适用
Booster and Catch-up Vaccination With Vaccine GSK1024850AHealthy volunteers (Vaccination against Streptococcus pneumoniae in healthy children previously enrolled in study 10PN-PD-DIT-037 (111188).)MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002140-27-Outside-EU/EEAGlaxoSmithKline Biologicals360
撤回
3 期
A phase 3 prospective, multicenter study to evaluate efficacy and safety of rVWF with or without ADVATE in elective surgical procedures in subjects with severe von Willebrand diseaseextended or excessive bleeding10035534NL-OMON42081Baxalta Innovations GmbH2
进行中（未招募）
1 期
n estudio multicéntrico de fase III realizado con un grupo paralelo aleatorizado y enmascaramiento para los evaluadores para comparar la eficacia y seguridad de dos formulaciones r-hFSH (AFOLIA frente a Gonal-f®) en mujeres para el tratamiento de reproducción asistida. A phase III assessor-blinded randomised parallel group multi-centre study to compare efficacy adn safety of two r-hFSH formulations (AFOLIA and Gonal-f®) in women for assisted reproductive treatment - not availableEstimulación del desarrollo de multiples folículos en pacientes femeninas que estan en tratamiento de reproducción asistida. Stimulation of multifollicular develoment in patients undergoing assisted reproductive treatmentEUCTR2010-019287-37-ESFinox AG372
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab in adult patients with active, moderate to severe thyroid eye diseaseEUCTR2020-001611-24-DEovartis Pharma GmbH70