EUCTR2018-002141-11-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation - GRAPHITE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 558
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. The subject or, when applicable, the subject's legally acceptable representative voluntarily signs and dates a written, informed consent form (ICF) and any required privacy authorization before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any
- •time without prejudice to future medical care.
- •2. Male or female subjects >18 years of age.
- •3. Subjects must undergo DNA-based HLA matching and be 8 of 8 or 7 of
- •8 HLA-matched (single allele or antigen mismatch at HLA-A, -B, and -C,
- •and HLA-DRB1 is allowable) unrelated hematopoietic stem cell
- •transplantation (HSCT) from either peripheral blood or bone
- •marrow stem cells for a hematologic malignancy or myeloproliferative
- •disorder. Subjects should follow local practice for additional HLA-match,
- •for example France, 9/10 or 10/10 HLA match.
- •4. Subjects for whom a myeloablative conditioning or RIC is planned.
- •5. Allo-HSCT eligible (meeting institutional criteria)-subjects planned medical care should include aGvHD prophylaxis with a combination of CNI (CYS or TAC) and MTX or CNI and MMF. With the exception of ATG (ATG-F or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded.
- •6. Status of the primary disease as follows:
- •a. Subjects with acute leukemia or chronic myelogenous leukemia: no
- •circulating blasts and <5% blasts in the bone marrow.
- •b. Subjects with myelodysplasia: no circulating blasts and <10% blasts in the bone marrow.
- •c. Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma with chemosensitive disease at the time of transplantation (partial or complete response to last salvage therapy).
- •d. Subjects with other nonHodgkin or Hodgkin lymphoma with a response to last salvage therapy or chemo-sensitive disease per institutional standards at the time of transplantation.
- •e. For subjects with myelofibrosis and other myeloproliferative disorders: <5% blasts in the blood and bone marrow.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of < 2 (Appendix E).
- •8. Sufficient cognitive ability to reliably complete the PML checklist at baseline.
- •9. Female subjects who are:
- •Postmenopausal for at least 1 year before signing of the informed consent, OR
- •Surgically sterile, OR
- •If they are of childbearing potential, must use a highly effective
- •method of contraception during the study and through 18 weeks after
- •the last dose of study drug, OR
- •If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 18 weeks after the last dose of study drug, OR
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should
- •not be used together.)
- •Male subjects, even if surgically sterilized (ie, status postvasectomy), who:
- •Agree to practice an acceptable effective barrier method of contraception during the entire study treatment period and through 18 weeks after the last dose of study drug, OR
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic absti
排除标准
- •1. Prior allo-HSCT.
- •2. Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in vivo or ex vivo T-cell depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin).
- •3. Planned allo-HSCT for nonmalignant hematological disorders (eg, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).
- •4. Known active cerebral/meningeal disease (including central nervous system involvement of the primary disease), or signs or symptoms of PML, any history of PML, or a positive PML subjective checklist before the administration of study drug on Day -1.
- •5. Evidence of encephalopathy at screening.
- •6. History of any major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
- •7. Prior or current therapy with a4 and/or ß7 integrin inhibitors
- •(including, but not limited to natalizumab, etrolizumab, AMG-181),
- •MAdCAM-1-antibodies, anti-CD11a mAb (eg, efalizumab) within 60 days
- •or 5 half-lives, whichever is longer from randomization.
- •8. Prior known exposure of the transplant recipient to vedolizumab.
- •9. Any serious medical or psychiatric condition that could, in the investigator or medical monitor's opinion, potentially interfere with the completion of treatment according to this protocol.
- •10. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, enitourinary, coagulation, immunological, endocrine/metabolic, neurologic or other medical disorder not related to the subject's primary disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- •11. Clinically active systemic infection during screening.
- •12. Clinically active cytomegalovirus (CMV) colitis during screening.
- •13. Clinically active Clostridium difficile infection or other intestinal pathogen during screening.
- •14. Active or latent tubercolosis (TB), regardless of treatment history, as
- •evidenced by any of the following: history of TB, OR positive
- •QuantiFERON test, OR T-Spot or 2 successive indeterminate
- •QuantiFERON tests, OR T-Spot tests OR a tuberculin skin test reaction =
- •10 mm (=5 mm in subjects receiving the equivalent of >15 mg/day
- •prednisone).
- •15. Chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive
- •[HBsAg+]) or hepatitis C infection (evident by active viral replication by
- •polymerase chain reaction [PCR] if hepatitis C virus antibody positive).
- •Hepatitis B core antibody (HBcAb) positive (HBcAb+) and negative for
- •hepatitis B surface antigen (HBsAg-) may be enrolled if viral DNA is
- •undetectable.
- •16. History of human immunodeficiency virus (HIV) positive test.
- •17. Treatment with anti-T-cells antibody such as alemtuzumab (anti- CD52), excluding ATG (ATG-F or thymoglobulin), within 4 months before the first dose of study drug on Day -1.
- •18. Treatment with any live vaccinations within 30 days before randomization.
- •19. If female, the subject is pregnant, lactating or breastfeeding, or intending to become pregnant before, during or within 18 weeks after participating in this study, or intending to donate ova during such time period.
- •Please refer to the Protocol for the others
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectioCrohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-000886-19-ATMillennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)96
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Long-Term Safety of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer PaiEUCTR2005-001725-28-ATGlaxoSmithKline R & D Limited750
进行中（未招募）
1 期
A Phase 2b study to demonstrate the safety and efficacy of Tildrakizumab in patients with Active Psoriatic ArthritisMedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000018188Psoriatic ArthritisEUCTR2016-003937-62-HUSUN Pharma Global FZE360
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes MellitusMedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2012-002414-39-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,202
已完成
2 期
A Study to Evaluate the Safety and Efficacy of Anamorelin HCL in Patients with Non Small Cell Lung CancerCTRI/2011/091/000299Helsinn Therapeutics US Inc228