NL-OMON54762招募中2 期
Phase 1/2 Dose Finding, Safety and Efficacy Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD) - PCYC-1146-IM
Pharmacyclics0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •1. Part A: Subjects with moderate or severe cGVHD after failure of 1
- •or more lines of systemic therapy.
- •2. Part B: Subjects with moderate or severe cGVHD after failure of 1
- •or more lines of systemic therapy, or subjects with new onset
- •moderate or severe cGVHD and in need of systemic
- •immunosuppression.
- •a. Subjects with new onset moderate or severe cGVHD must not
- •have received previous systemic therapy for cGVHD with the
- •exception of corticosteroids received within 72 hours prior to
- •signing the informed consent form.
- •b. Subjects with newly diagnosed cGVHD may be receiving
- •other immunosuppressants for the prophylaxis or treatment of
- •acute GVHD, but if the subject is receiving prednisone for
- •prophylaxis or treatment of acute GVHD it must be at or below
- •0.5 mg/kg/d at the time of enrollment.
- •3. History of allogeneic stem cell transplantation
- •Part A: >=1 to <12 years of age at the time of enrollment
- •Part B: >=1 to <22 years of age at the time of enrollment
- •5.Written informed consent or parental or guardian permission and
- •assent of children capable of understanding the nature of the study,
- •per country-specific or site-specific standards
- •6. Ability of subject or, if a minor, parent/guardian to understand the
- •purpose and risks of the study and to provide a signed and dated
- •parental permission and authorization to use protected health
- •information (in accordance with national and local subject privacy
- •regulations); willingness of child to provide an assent, if
- •developmentally able to do so.
排除标准
- •Disease-Related
- •1. Presence of single organ genito-urinary involvement as the only
- •manifestation of cGVHD.
- •Concurrent Conditions
- •2. Received an investigational agent within 28 days before enrollment.
- •3. Received donor lymphocyte infusion (DLI) within 56 days before
- •enrollment.
- •4. Progressive underlying malignant disease or active post-transplant
- •lymphoproliferative disease.
- •5. Ongoing anticoagulation treatment with warfarin or equivalent
- •vitamin K antagonist.
- •6. History of other malignancy (not including the underlying
- •malignancy that was the indication for transplant), with the
- •following exceptions:
- •Malignancy treated with curative intent and with no evidence of
- •active disease present for more than 3 years prior to enrollment
- •and felt to be at low risk for recurrence by treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo
- •maligna melanoma without current evidence of disease
- •Adequately treated cervical carcinoma in situ without current
- •evidence of disease
- •7. History of major surgery within 28 days before enrollment or lack
- •of full recovery from surgery.
- •8. Any life-threatening illness, medical condition, or organ system
- •dysfunction that, in the investigator*s opinion, could compromise
- •the subject*s safety or put the study outcomes at undue risk.
- •9. Female subject who is pregnant, breastfeeding, or planning to
- •become pregnant while enrolled in this study or within 3 months of
- •the last dose of study drug. Male subject who plans to father a child
- •while enrolled in this study or within 3 months after the last dose of
- •study drug.
- •10. Unwilling or unable to participate in all required study evaluations
- •and procedures.
研究者
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