NCT01616680撤回2 期
Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium1 个研究点 分布在 1 个国家开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin
研究概览
简要总结
The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)
详细描述
PRIMARY OBJECTIVES:
I. Determine whether the complete and partial response rate of steroid-resistant skin GVHD exceeds 25% after administration of brentuximab vedotin.
SECONDARY OBJECTIVES:
I. Evaluate the effect of brentuximab vedotin on the clinical manifestations of acute GVHD of the liver and gastrointestinal tract.
II. Determine the incidence and degree of brentuximab vedotin-related toxicity when administered after allogeneic hematopoietic cell transplantation (HCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients with steroid-resistant stage 2 or 3 acute GVHD of the skin with or without involvement of other organs; patients must have received initial therapy with prednisone or methylprednisolone at a prednisone-equivalent dose of at least 1.0 mg/kg/day alone or combined with other agents, including psoralen and ultraviolet A (PUVA), with:
- •Flare of rash involving at least 25% of the body surface at any time after starting prednisone for GVHD treatment, OR
- •Rash involving more than 50% of the body surface persisting after at least 1 week of initial treatment, OR
- •Rash involving at least 25% of the body surface persisting after at least 2 weeks of initial treatment
- •Concomitant use of steroids is permitted; steroid dose should not have been increased within a week prior to enrollment
- •Patient, guardian or legally authorized representative is able and willing to provide informed consent
- •Willing to use effective contraception; both women of childbearing potential and men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug
排除标准
- •Prior second-line systemic treatment for GVHD
- •Absolute neutrophil count (ANC) < 2000/μL
- •Administration of growth factor in order to maintain the ANC > 2000/μL
- •Platelet count < 30,000/μL, (unsupported)
- •Serum total bilirubin concentration > upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3X ULN
- •Calculated creatinine clearance < 60 ml/min
- •Peripheral neuropathy: clinical total neuropathy score (TNS) score > 2
- •Any Grade 3 or higher uncontrolled active infection within 1 week before enrollment
- •Bullous formation or desquamation related to GVHD (stage 4 skin GVHD)
- •Evidence of recurrent/persistent malignancy by cytogenetics, histology or flow cytometry
- •GVHD after donor lymphocyte infusion (DLI)
- •Clinical manifestations of chronic skin GVHD
- •Women who are pregnant or lactating; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days before the first dose of brentuximab vedotin; woman of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
- •Patients with a known hypersensitivity to brentuximab vedotin
- •History of Progressive multifocal leukoencephalopathy (PML)
研究组 & 干预措施
Supportive care (brentuximab vedotin)
Experimental
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15.
干预措施: brentuximab vedotin (Drug)
Supportive care (brentuximab vedotin)
Experimental
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15.
干预措施: laboratory biomarker analysis (Other)
Supportive care (brentuximab vedotin)
Experimental
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15.
干预措施: pharmacological study (Other)
结局指标
主要结局
Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin
时间窗: Up to day 28
次要结局
- Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin(Up to day 28)
- Incidence and severity of brentuximab vedotin-related toxicity after allogeneic HCT defined graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4(Assessed up to day 45)
研究者
研究点 (1)
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