EUCTR2021-003450-22-SE进行中（未招募）1 期
Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female of any age.
- •2. Has undergone allogeneic (including umbilical cord) cell transplantation =21 days prior to dosing and has demonstrated engraftment with an absolute neutrophil count >500/mm3, AND has one of the following:
- •a. AdV viremia DNA =10,000 copies/mL at screening, OR
- •b. Two consecutive and rising AdV viremia DNA results of =1,000 copies/mL at screening, AND
- •i. has absolute lymphocyte count <180/mm3, OR
- •ii. has received T cell depletion, OR
- •iii. had a cord blood transplant.
- •3. Males and females of childbearing potential who engage in heterosexual intercourse must agree to use contraception as detailed in Appendix 5 of this protocol and refrain from donating sperm or eggs for at least 90 days after treatment completion.
- •4. Willing and able to provide signed informed consent.
- •5. Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Grade 3 or higher acute GVHD (see Appendix 6 for information on acute GVHD grading and severity).
- •2. Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent). Patients actively undergoing corticosteroid tapering during Screening may randomize and dose once they have reached = 1.0 mg/kg/day with Medical Monitor approval, with the expectation that the corticosteroid taper will continue.
- •3. Has either of the following laboratory parameters at screening:
- •a. Aspartate aminotransferase and alanine aminotransferase serum levels =5 times the
- •upper limit of normal (ULN), OR
- •b. Direct bilirubin serum levels =3 times the ULN.
- •4. Relapse of primary malignancy, or any other active malignancy, except for non-melanoma skin cancer. Malignancies that are slow growing and/or stable may be allowed with Medical Monitor approval.
- •5. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated) regardless of attribution ongoing or within 7 days prior to randomization.
- •6. Uncontrolled viral (other than AdV), bacterial, or fungal infection(s) leading to hemodynamic instability or radiologic or laboratory evidence attributable to worsening disease.
- •7. Requirement for fraction of inspired oxygen (FiO2) >0.5 (ie, 50%) to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation, except for planned procedures or surgeries with Medical Monitor approval.
- •8. Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to dosing.
- •9. Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to dosing.
- •Other protocol-defined criteria apply.
研究者
相似试验
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVRespiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-002023-11-HUJanssen-Cilag International NV737
进行中（未招募）
1 期
Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.Type 1 Diabetes MellitusEUCTR2014-005153-39-LTexicon Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVEUCTR2020-002023-11-SEJanssen-Cilag International NV737
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2014-004464-38-NLAmgen Inc852
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)Immunoglobulin A Nephropathy (IgAN)EUCTR2020-003084-26-CZChinook Therapeutics U.S., Inc.320