2024-518940-19-02招募中2 期
Pentaglobin as early adjuvant treatment for febrile neutropenia in acute leukemia or allogeneic hematopoietic stem cell transplant patients colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa
Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月28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
- 120
- 试验地点
- 6
- 主要终点
- This study will have two co-primary endpoints: • To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) (earlier primary endpoint). To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls (later primary endpoint).
研究概览
简要总结
To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae (CRE) or by any Pseudomonas aeruginosa (PA).
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
- •Age > or = 18 years
- •Men enrolled in the study with partners who are women of child bearing potential, must be willing to use an acceptable barrier contraceptive method during the trial.
- •Performance status: ECOG <3
- •Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy or Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed)
- •Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab or pre-treatment bloodstream infection sustained by CRE or PA
- •Written and signed informed consent
- •Patients participating in other clinical studies for allogeneic HSCT are also eligible to this study if the above-mentioned trials are using an approved investigational compound
- •Possibility of starting treatment with Pentaglobin <12 hours after development of fever
- •Treatment with other immunoglobulins (e.g. IVIG, Cytotect) should be not administered during the time of treatment with Pentaglobin.
- •Women of child-bearing potential enrolled in the study must have a negative pregnancy test at screening and agree to use two distinct acceptable methods of contraception during the trial.
排除标准
- •Uncontrolled systemic infection
- •Hypersensitivity to the active substance or to any of the excipients of Pentaglobin
- •Patients with previous anaphylaxis or severe reactions to immunoglobulins preparation
- •Severe concomitant illness: o patients with severe renal impairment o patients with severe pulmonary impairment o patients with severe cardiac impairment o patients with severe hepatic impairment
- •Patients who on the basis of the investigator's consideration are not able to give the informed consent.
- •Pregnancy or lactation.
结局指标
主要结局
This study will have two co-primary endpoints: • To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) (earlier primary endpoint). To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls (later primary endpoint).
This study will have two co-primary endpoints: • To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) (earlier primary endpoint). To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls (later primary endpoint).
次要结局
- OS in CRE or PA carriers not developing a bloodstream infection sustained the colonizing agent at 4 months from the start of intensive chemotherapy or transplant; Days of fever > 38.3°C at 30 days from the day of start intensive chemotherapy or from day of transplant. Days of hospitalization at 30 days from the start of intensive chemotherapy or from day of transplant; Days of i.v. antimicrobials at 30 days from the start of intensive chemotherapy or from day of transplant.
- Non-relapse mortality (NRM) at 4 months from the start of intensive chemotherapy or transplant; Incidence and severity of adverse drug reactions (ADR) classified by System Organ Class (SOC) and preferred term (PT) at 30 days from start treatment with Pentaglobin; Incidence and severity of acute GvHD at 120 days from day of transplant. Incidence and severity of chronic GvHD at 1 year day of transplant.
- The cumulative incidence of graft failure / time to neutrophil and platelet recovery at 30 and 60 days from the day of start intensive chemotherapy or from day of transplant. One year probability of GRFS (GvHD free, relapse free survival) from the day of start intensive chemotherapy or from day of transplant.
研究者
Trial Office GITMO
Scientific
Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare
研究点 (6)
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