The Efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) Salvage Chemotherapy With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD - Multicentre Phase II Clinical Study - PLRG-HL1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 13
- 主要终点
- PFS (progression-free survival)
研究概览
简要总结
The objective of the study is evaluation of efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) salvage therapy with autologus stem cell transplantation (ASCT) consolidation in advanced classical Hodgkin lymphoma patients not responding to ABVD therapy.
详细描述
Treatment regimen:
Bendamustine (B) 90 mg/m2 iv day 1, 2 Gemcytabine (G) 800 mg/m2 iv day 1, 4 Dexamethasone (D) 40 mg iv/po day 1,2,3,4
Course of treatment every 21-28 days, 4 courses of treatment max; next round of treatment may be given if ANC>1000/μl and PLT>75000/μl. Up to 7-day delay is permitted.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Classical Hodgkin's Lymphoma treated with ABVD regimen with PET scan/CT performed before, during and after treatment, and also one of the following:
- •positive result (Deauville 4 and 5) of early PET scan after 2 ABVD courses
- •disease progression or relapse after first-line ABVD treatment or ABVD and radiotherapy combination treatment
- •No contraindications for salvage chemotherapy and ASCT
- •At least one measurable malignancy
- •ECOG performance status ≤ 3
- •Written signed and dated informed consent prior to any study procedures being performed
排除标准
- •Non-Classical Hodgkin's Lymphoma
- •Other than ABVD first-line treatment, preceding patient's inclusion
- •Lack of PET scans performed in accordance with inclusin criteria during ABVD treatment
- •Transformation of Hodgkin's Lymphoma
- •Central Nervous System (CNS) Metastases
- •Contraindications for ASCT or lack of patient's consens for the procedure
- •Second malignancy - active or cured less than 5 years prior
- •Uncontrolled diabetes
- •Hepatic impairment (bilirubin concentration ≥ 1.5 x ULN, SGOT > 5 x ULN), if non-realted to the lymphoma or Gilbert's syndrome
- •HIV infection
- •Active HBV or HCV infection. Subjects who have had Hepatitis B and are abHBC positive, need to undergo HBV DNA test using a Polymerase Chain Reaction (PCR) technique and be applied appropriate preventive treatment.
- •Pregnancy or lactation
- •Hypersensitivity to any of the drugs
- •Lack of written informed consent
研究组 & 干预措施
BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
干预措施: Bendamustine (Drug)
BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
干预措施: Gemcitabine (Drug)
BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
干预措施: Dexamethasone (Drug)
BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
干预措施: PET/CT (Diagnostic Test)
BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
干预措施: Autologous Stem Cell Transplant (Procedure)
结局指标
主要结局
PFS (progression-free survival)
时间窗: Time measured from date of of Cycle 2 of BGD treatment (every cycle is 21-28 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Staying free of disease progression.
ORR (overall response rate)
时间窗: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
CR (complete response) + PR (partial response)
次要结局
- OMRR (overall metabolic response rate)(Evaluated a the end of Cycle 2 of BGD treatment (every cycle is 21-28 days) and after ASCT (up to 150 days after Day 1 of Cycle 1 of BGD treatment).)
- MR (mobilization rate)(Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).)
- BGD tolerability assessment.(24 months from the start of BGD treatment)
- OS (overall survival)(Time measured from Day 1 of Cycle 1 of BGD treatment (every cycle is 21-28 days) until the date of death from any cause, assessed up to 24 months (measured for patients that have undergone ASCT after BGD tratment).)