AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy - AGAVE-201

Syndax Pharmaceuticals, Inc.0 个研究点目标入组 210 人开始时间: 2021年9月21日最近更新: 2021年11月29日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Syndax Pharmaceuticals, Inc.
入组人数: 210

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. Patient must be 18 years of age or older, at the time of signing the informed consent.
•2. Patients who are allogeneic HSCT recipients with active cGVHD requiring systemic immune suppression.
•Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD (Jagasia 2015).
•3. Patients with refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy.
•- Refractory disease defined as meeting any of the following criteria:
•- The development of 1 or more new sites of disease while being treated for cGVHD.
•- Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD.
•- Patients who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.
•- Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.
•4. Patients may have persistent active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
•5. Karnofsky Performance Scale of =60 (if aged 16 years or older); Lansky Performance Score of =60 (if aged <16 years).
•6. Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization as follows:
•- Absolute neutrophil count =1.0 × 10^9/L without growth factors within 1 week of study entry)
•- Platelet count =50 × 10^9/L (without transfusion within 2 weeks of study entry)
•- ALT, and aspartate aminotransferase (AST) = 2.5 × upper limit of normal (ULN) and total bilirubin =1.5 × ULN.
•- For patients with suspected or documented liver cGVHD, ALT and AST =5 x ULN and total bilirubin =1.5 × ULN.
•7. Creatinine clearance (CrCl) =30 mL/min/1.73 m2 based on the Cockcroft-Gault formula in adult patients and Schwartz formula in pediatric patients.
•8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•9. Concomitant use a of systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a patient is taking corticosteroids at study randomization, the following criteria must be met:
•- Be on a stable dose of corticosteroids for at least 2 weeks prior to Cycle 1 Day 1.
•10. Concomitant use of CNI or sirolimus is allow but not required.
•11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A parent/legal guardian should provide consent for pediatric patients unable to provide consent themselves, in addition, where applicable pediatric patients should sign their own assent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 116
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

排除标准

•1. Has acute GVHD without manifestations of cGVHD.
•2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
•3. History of acute or chronic pancreatitis.
•4. History of myositis.
•5. History or other evidence of severe illness, uncontrolled infection, allergy to excipients (see formulation details in Investigator Brochure), or any other conditions that would make the patient, in the opinion of the Investigator, unsuitable for the study.
•6. Patients with acquired immune deficiency syndrome (AIDS).
•7. Patients with a of history of latent or active TB before screening; signs or symptoms suggestive of active TB upon medical history and/or physical examination; recent close
•contact with a person with active TB; positive QuantiFeron TB test at screening.
•8. Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid [DNA], or HBV positive core antibody alone with positive HBV DNA. Hepatitis C (defined as positive hepatitis C [HCV] antibody with positive HCV ribonucleic acid [RNA]).
•9.Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor’s Medical Monitor (eg, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
•10. Female patient who is pregnant or breastfeeding.
•11. Previous exposure to CSF1-R targeted therapies.
•12. Taking agents for treatment of cGVHD other than corticosteroids and either a CNI or sirolimus is prohibited. See Inclusion Criteria 9 and 10 for guidelines regarding the appropriate use of corticosteroids, CNI, and sirolimus in combination with study treatment.
•13. For approved or commonly used agents, other than corticosteroids, CNI and sirolimus, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.
•14. Receiving an investigational treatment within 28 days of randomization.
•15. Patients should not be participating in any other interventional study. Pediatric patients are encouraged to also participate in the ongoing development studies of the Pediatric cGVHD Symptom Scale (PCSS).

研究者

发起方

Syndax Pharmaceuticals, Inc.

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