NCT06663722招募中2 期
A Phase II b Study of Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Best Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of allogeneic hematopoietic cell transplantation (HCT).
- •Age greater or equal to
- •Chronic GVHD per 2014 National Institutes of Health Consensus Criteria (NCC) (Jagasia et al. 2015) or overlap syndrome requiring new therapy in patients with at least 2 prior lines of therapy, steroid refractoriness, or steroid dependence:
- •Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such as ruxolitinib, belumosudil, or ibrutinib. GVHD prophylaxis does not count as a prior line of therapy.
- •Steroid refractory is defined as any of the following criteria:
- •i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week
- •ii. Manifestations persist without improvement despite treatment with ≥ 0.5 mg/kg/day or 1 mg/kg every other day for at least four weeks.
- •iii. Recurrence after a CR, or
- •iv. Progression after a PR.
- •Steroid dependence is defined as inability to control cGVHD symptoms while tapering prednisone below 0.25 mg/kg/day on at least two occasions separated by at least 8 weeks. There must be evidence of clinically active cGVHD.
- •For patients receiving approved or commonly used agents, all GVHD systemic treatments should be discontinued except for corticosteroids and drugs being continued from GVHD prophylaxis at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening.
- •Platelet count > 50,000 platelets/μL and absolute neutrophil count > 1,000 cells/μL as measured at Screening.
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), unless attributed to presumed cGVHD as measured at Screening.
- •Stable dose of corticosteroids for at least 14 days prior to treatment.
- •Sexually mature individuals must use contraception as described in Section 4.
- •For individuals less than 18 years of age, sexual maturity will be determined as per treating pediatrician.
排除标准
- •Pregnancy or breast-feeding.
- •Active relapse of underlying malignancy.
- •History or the presence of interstitial pneumonitis or drug-related pneumonitis.
- •Active gastrointestinal (GI) bleeding.
- •Inability to tolerate volume shifts associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function (ejection fraction (EF) < 40%) per Investigator discretion.
- •History of myositis.
- •History of splenectomy.
- •History of pancreatitis.
- •History of other malignancy (within 3 years of Screening) unless treated with curative intent and approved by Principal Investigator (PI).
- •Significant, uncontrolled, or active comorbid conditions or are unable to adhere to the study requirements.
- •Acquired Immune Deficiency Syndrome (AIDS) or active hepatitis B (Hep B) or active hepatitis C (Hep C) infection.
- •Prior colony-stimulating factor-1 (CSF-1R) targeted therapies.
- •Prior history of ECP treatment failure or intolerance.
- •Intolerance to methoxsalen, heparin, or citrate products.
- •Patients with aphakia due to risk of increased retinal damage or photosensitive disease (albinism, systemic lupus erythematosus, porphyria).
- •Lack of stable IV access. Acceptable forms include central venous catheter, peripherally inserted central catheter (PICC), or peripheral IV line per institutional guidelines.
- •Insurance denial of coverage for the ECP procedure.
研究组 & 干预措施
Axatilimab in combination with ECP Group
Experimental
Participants in this group will receive Axatilimab in combination with extracorporeal photopheresis (ECP) therapy for up to seven (7) four-week cycles.
Total participation duration is about 15 months.
干预措施: Axatilimab (Biological)
Axatilimab in combination with ECP Group
Experimental
Participants in this group will receive Axatilimab in combination with extracorporeal photopheresis (ECP) therapy for up to seven (7) four-week cycles.
Total participation duration is about 15 months.
干预措施: Extracorporeal Photopheresis (Procedure)
结局指标
主要结局
Best Overall Response Rate (ORR)
时间窗: Up to 24 weeks
Best overall response rate (ORR) will be reported as the percentage of participants who achieve partial response (PR) or a complete response (CR) to study therapy, as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in chronic graft-versus-host disease (cGVHD) while on study treatment.
次要结局
- Proportion of participants experiencing serious adverse events (SAEs)(Up to 15 months)
- Change in cumulative dose of corticosteroid usage(Baseline, 24 weeks, 1 year)
- Duration of response (DOR)(Up to 15 months)
- Relapse-free survival (RFS)(Up to 15 months)
- Proportion of participants experiencing treatment-related adverse events (AEs)(Up to 15 months)
- Change in Quality of life (QoL) as measured by the modified Lee Symptom Scale (mLSS) score(Baseline, 24 weeks, 1 year)
- Proportion of participants who develop subsequent sclerotic skin disease(Up to 15 months)
- Rate of Complete Response (CR) at Best Response(Up to 24 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid TumorsAdvanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmRecurrent Malignant Solid NeoplasmRefractory Malignant Solid NeoplasmNCT06320405OHSU Knight Cancer Institute38
进行中（未招募）
2 期
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host DiseaseChronic Graft-versus-host-diseaseNCT06388564Incyte Corporation130
招募中
1 期
Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic LeukemiaAtypical Chronic Myeloid LeukemiaMyelodysplastic/Myeloproliferative NeoplasmRecurrent Myelodysplastic/Myeloproliferative NeoplasmRecurrent Myeloproliferative NeoplasmRefractory Chronic Myelomonocytic LeukemiaRefractory Myelodysplastic/Myeloproliferative NeoplasmRefractory Myeloproliferative NeoplasmChronic Myelomonocytic LeukemiaNCT06523556Uma Borate49
招募中
1 期
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast CancerPALB2-Mutated Breast CarcinomaHER2-negative Breast CancerBRCA1 MutationBRCA2 MutationBreast CancerNCT06488378Dana-Farber Cancer Institute20
招募中
3 期
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseaseChronic Graft-versus-host-diseaseNCT06585774Incyte Corporation240