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临床试验/EUCTR2017-004981-85-NL
EUCTR2017-004981-85-NL进行中（未招募）1 期

A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) - ReSPECT

Cidara Therapeutics, Inc.0 个研究点目标入组 462 人开始时间: 2020年1月7日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
462
研究概览入排标准研究者记录与标识符相似试验

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. Willing and able to provide written informed consent.
  • •2. Males or females =18 years of age.
  • •3.Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  • •4. Diagnosed with 1 of the following underlying diseases:
  • •a. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
  • •b. Acute lymphoblastic leukemia, in first or second complete remission.
  • •c. Acute undifferentiated leukemia in first or second remission.
  • •d. Acute biphenotypic leukemia in first or second complete remission.
  • •e. Chronic myelogenous leukemia in either chronic or accelerated phase.
  • •f. One of the following myelodysplastic syndrome(s) defined by the following:
  • •i. Refractory anemia.
  • •ii. Refractory anemia with ringed sideroblasts.
  • •iii. Refractory cytopenia with multilineage dysplasia.
  • •iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.
  • •v. Refractory anemia with excess blasts – 1 (5–10% blasts).
  • •vi. Refractory anemia with excess blasts – 2 (10–20% blasts).
  • •vii. Myelodysplastic syndrome, unclassified.
  • •viii. Myelodysplastic syndrome associated with isolated del (5q).
  • •ix. Chronic myelomonocytic leukemia.
  • •g. Lymphoma (including Hodgkin’s) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant.
  • •h. Aplastic anemia.
  • •i. Primary or secondary myelofibrosis.
  • •5. Receiving myeloablative or reduced-intensity conditioning regimens.
  • •6. Adequate renal and hepatic function prior to initiation of conditioning
  • •regimen, therefore between 40 days prior and 10 days prior to BMT,
  • •documented as follows:
  • •a. Hepatic: alanine aminotransferase =2.5 × upper limit of normal (ULN)
  • •and total serum bilirubin =1.5 × ULN (excluding Gilbert's Syndrome).
  • •b. Renal: serum creatinine =2 mg/dL and with creatinine clearance
  • •(CrCl) >30 mL/min without a history of renal transplant, or undergoing
  • •weekly dialysis within 4 weeks of the BMT.
  • •7. Baseline blood samples drawn for serum Platelia galactomannan enzyme immunoassay (GM EIA) and ß-D glucan levels within 14 days before randomization, with results available prior to randomization.
  • •8. Baseline Toxoplasma serologies available within 6 weeks prior to randomization.
  • •9. Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • •testing with no evidence of G6PD deficiency performed within 6 weeks
  • •prior to randomization.
  • •10. Female subjects of child-bearing potential <2 years post-menopausal
  • •(unless surgically sterile)must agree to and comply with using one
  • •barrier method (e.g., female condom with spermicide) plus one other
  • •highly effective method of birth control (e.g., oral contraceptive, implant,
  • •injectable, indwelling intrauterine device, vasectomized partner), or
  • •sexual abstinence (only possible if it corresponds to the subject's usual
  • •lifestyle) while participating in this study, and for 30 days after the last
  • •dose of study drug. Male subjects must be vasectomized, abstain from
  • •sexual intercourse, or agree to use barrier contraception (condom with
  • •spermicide), and agree not to donate sperm while participating in the
  • •study and for 120 days from the last IV dose of study drug.
  • •Definitions:
  • •Woman of childbearing potential: fertile, following menarche and until
  • •becoming post-menopausal unless permanently sterile. Permanent
  • 另有 2 项未显示

排除标准

  • •1. Diagnosis of AML not in morphological remission.
  • •2. Diagnosis of chemotherapy-resistant lymphoma.
  • •3. Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks
  • •of screening.
  • •4. Diagnosed symptomatic heart failure or with left ventricular ejection
  • •fraction (LVEF) at rest =50%, or shortening fraction =26%.
  • •5. Personal or family history of Long QT interval on ECG (QT) syndrome
  • •or a prolonged QT interval corrected for heart rate by Fridericia's
  • •formula (QTcF) (>470 msec in males and >480 msec in females); or
  • •concurrent administration of terfenadine, cisapride, astemizole,
  • •erythromycin, pimozide, quinidine, or halofantrine (Appendix 6A).
  • •6. Diagnosed reduced lung function with either diffusion capacity
  • •(corrected for hemoglobin) or forced expiratory volume in 1 second
  • •(FEV1) =80% of predicted value, or O2 saturation =85% on room air.
  • •7. Suspected or documented PCP within 2 years of screening.
  • •8. Positive baseline serum Platelia GM EIA (= 0.5) and/or ß-D glucan
  • •assay (=80 pg/mL).
  • •9. Receipt of previous allogeneic BMT.
  • •10. Planned receipt of cord blood for transplantation.
  • •11. Planned peripheral blood or marrow autograft.
  • •12. Underlying diagnosis of multiple myeloma.
  • •13. Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory
  • •neuropathy, per NCI CTCAE version 5.0.
  • •14. History of severe ataxia, neuropathy or tremors; or a diagnosis of
  • •multiple sclerosis or a movement disorder (including Parkinson's disease
  • •or Huntington's disease).
  • •15. a. Planned or ongoing intake at screening of a known neurotoxic
  • •medication (see Appendix 5).
  • •b. Any contraindication or a medication or supplement known to severely
  • •interact with the standard antimicrobial regimen (SAR) as detailed in the
  • •Summary of Product Characteristics (SmPC) of fluconazole,
  • •posaconazole, or TMP/SMX (see Appendix 6B, Appendix 6C, or Appendix
  • •6D, respectively).
  • •16. Known hypersensitivity to Rezafungin for Injection, any
  • •echinocandin, fluconazole, posaconazole, other azole antifungal, or to
  • •any of their excipients.
  • •17. Known hypersensitivity or inability to receive TMP/SMX or any of its
  • •excipients, including but not limited to anaphylaxis, exfoliative skin
  • •disorders, or acute porphyria.
  • •18. Recent use of an investigational medicinal product within 28 days or
  • •greater to assure more than 5 half-lives have passed to prevent
  • •overlapping toxicities when this study's investigational product is dosed,
  • •or presence of an investigational device at the time of screening.
  • •19. Known infection with HIV. Subjects with unknown HIV status should
  • •be tested for HIV antibodies per standard of care.
  • •20. Pregnant or lactating females.
  • •21. The Principal Investigator (PI) determines that the subject should
  • •not participate in the study.
  • •22. Considered unlikely to follow up for 90 days after receipt of the BMT
  • •due to logistic concerns (i.e., location relative to transplant center).
  • 另有 4 项未显示

研究者

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