NL-OMON48950撤回不适用
A Phase I/II open-label, single-arm, multi-center study of ruxolitinib added to corticosteroids in pediatric patients with grade II-IV acute graft vs. host disease after allogeneic hematopoietic stem cell transplantation - CINC424F12201 (REACH 4).
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 4
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 17（—）
入选标准
- •For a full list of inclusion criteria, refer to Section 5.1. Key inclusion criteria include:
- •* Male or female patients age *28 days and <18 years at the time of informed
- •* Patients who have undergone alloSCT from any donor source (matched unrelated
- •donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or
- •cord blood. Recipients of myeloablative or reduced intensity conditioning are
- •* Patients with a confirmed diagnosis of grades II-IV aGvHD within 48 hours prior to
- •study treatment start. Biopsy confirmation of aGvHD is recommended but is not
- •required. Enrollment should not be delayed awaiting biopsy or pathology results.
- •Should the biopsy results not confirm aGvHD, however, the patient must discontinue
- •from the study if study treatment has already been started. Patients may have
- •either: Treatment-naïve aGvHD as per Table 8-2 (Harris et al. 2016) OR Steroid
- •refractory aGvHD as per institutional criteria, and the patient is currently receiving
- •systemic corticosteroids.
- •* Evident myeloid engraftment with ANC > 1,000/*l and platelet count >20,000/*l.
- •(Use of growth factor supplementation and transfusion support is allowed.)
排除标准
- •For a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include:
- •* Has received the following systemic therapy for aGvHD: a) Treatment-naïve aGvHD
- •patients have received any prior systemic treatment of aGvHD except for a
- •maximum 72h of prior systemic corticosteroid therapy of methylprednisolone or
- •equivalent after the onset of acute GvHD. Patients are allowed to have received
- •prior GvHD prophylaxis which is not counted as systemic treatment (as long as the
- •prophylaxis was started prior to the diagnsosis of aGvHD);
- •b) SR-aGvHD patients have received two or more prior systemic treatments for aGvHD in
- •addition to corticosteroids
- •* Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome
- •with both acute and chronic GvHD features (as defined by Jagasia et al 2015).
- •* Failed prior alloSCT within the past 6 months.
- •* Presence of relapsed primary malignancy, or who have been treated for relapse
- •after the alloSCT was performed, or who may require rapid immune suppression
- •withdrawal of immune suppression as pre-emergent treatment of early malignancy
- •* Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI)
- •administered for pre-emptive treatment of malignancy recurrence. Note: Patients
- •who have received a scheduled DLI as part of their transplant procedure and not for
- •management of malignancy relapse are eligible.
- •* Any corticosteroid therapy for indications other than aGvHD at doses > 1 mg/kg/day
- •methylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7 days of
- •Screening. Routine corticosteroids administered during conditioning or cell infusion
- •is allowed.
- •* Patients who received JAK inhibitor therapy for any indication after initiation of
- •current alloSCT conditioning.
研究者
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