2024-520020-28-00招募中2 期
PILOT ANTI-CMV CLINICAL TRIAL: PROPHYLAXIS OF CYTOMEGALOVIRUS INFECTION IN HLA-IDENTICAL FAMILIAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH ADVANCED CELLULAR IMMUNOTHERAPY IN PATIENTS WITHOUT SPECIFIC PHARMACOLOGYCAL PROPHYLAXIS AVAILABLE
Instituto De Investigacion Marques De Valdecilla3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月17日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- efficacy is the incidence of CMV infection AT DAY 100 POST-TPH (measured as viral load >200 copies in 2 determinations or >1000 in 1 determination [PCRq]).
研究概览
简要总结
To evaluate the efficacy of antiviral prophylaxis with specific CTLs against CMV in reducing the incidence of CMV infection at 100 days posttransplant, according to historical controls of the haematology service of the Hospital Universitario Marqués de Valdecilla
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
- •Adult patients (over 18 years of age), whether or not diagnosed with hematologic malignancy, who have received an allogeneic HSCT hematopoietic progenitor transplant from HLA-identical family donors
- •b. The donor will be screened to determine suitability according to the HSCT hematopoietic progenitor donor evaluation criteria
- •C. The donor has to also sign a written informed consent prior to inclusion
- •Non-candidates to receive Letermovir
- •Source of HSC progenitors: peripheral blood or bone marrow
- •Patients whose donor is CMV seropositive
- •Negative pregnancy test in women
- •Written informed consent signed by the patient or legal representative
- •Partial recovery of the hematopoietic implant (absolute neutrophil count >0.5 x10^9 cells/L for at least 3 consecutive post-HSCT determinations)
- •Specific inclusion criteria for donors:
- •a. Donors will be selected if they meet HLA identity criteria and are CMV seropositive
排除标准
- •MUST NOT MEET ANY OF THE ESTABLISHED CRITERIA for the prescription of LETERMOVIR in CMV seropositive adult recipients of an allogeneic HSCT:
- •ECOG > or = 3
- •Organ toxicity greater than grade 3 according to CTCAE Version 5.0
- •Uncontrolled infection, defined by fever and/or hemodynamic instability and/or unresolved infectious focus.
- •Persistent fever (>38ºC) in the 3 days prior to the infusion
- •Relapse or active and uncontrolled progression of the malignant disease
- •CMV viral reactivation prior to the day of infusion (21 post-HSCT) requiring anti-viral treatment (more than 200 copies of CMV by PCR in 2 determinations or more than 1000 in 1 determination).
- •Previous therapy with Letermovir
- •Specific exclusion criteria for donors:
- •a. Active infection at the time of lymphoapheresis
- •Related donor with at least one mismatch at one of the HLA locus (HLA-A, -B or -DR)
- •Haploidentical donor
- •Unrelated donor with at least one mismatch at one of the four HLA gene loci (HLA-A, -B, -C and -DRB1)
- •Use of cord blood
- •Use of graft with ex vivo T-lymphocyte depletion
- •GvHD grade 2 or higher requiring the use of systemic corticosteroids (doses ≥1mg/kg/day of prednisone or equivalent doses of other corticosteroids
- •AND MUST NOT MEET ANY OF THE CRITERIA BELOW to participate in the study:
- •Treatment at the time of cell infusion with corticosteroid doses greater than 0.5mg/kg/day of prednisone or equivalents
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
efficacy is the incidence of CMV infection AT DAY 100 POST-TPH (measured as viral load >200 copies in 2 determinations or >1000 in 1 determination [PCRq]).
efficacy is the incidence of CMV infection AT DAY 100 POST-TPH (measured as viral load >200 copies in 2 determinations or >1000 in 1 determination [PCRq]).
次要结局
- Assess the need for CMV treatment
- To evaluate the incidence of CMV disease
- to assess the presence of allogeneic CMV-specific memory T lymphocytes
研究者
mar garcia
Scientific
Instituto De Investigacion Marques De Valdecilla
研究点 (3)
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