NCT06941688终止2 期
Phase II, Multicentre, Randomized Study of Decitabine Plus GemOx Versus GemOx for Relapsed/Refractory Peripheral T-cell Lymphoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and oxaliplatin as a second-line or later treatment. This clinical trial is based on a review of existing literature, which supports the rationale for using this three-drug combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria to be considered eligible.
- •Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have either relapsed after first-line chemotherapy or experienced disease progression due to refractory disease, and who are deemed eligible for further chemotherapy.
- •Age ≥ 19 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate bone marrow function, defined as:
- •White blood cell count ≥ 3,000/μL
- •Absolute neutrophil count ≥ 2,000/μL
- •Platelet count ≥ 75,000/μL
- •Hemoglobin ≥ 8.0 g/dL Note: Transfusions within 1 week prior to screening are not permitted.
- •Adequate renal function, defined as serum creatinine ≤ 1.5 × upper limit of normal (ULN).
- •Adequate hepatic function, defined as:
- •Serum total bilirubin ≤ 1.5 × ULN
- •AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) Note: Patients with hepatic dysfunction due to underlying disease may be enrolled at the investigator's discretion.
- •Presence of measurable disease.
- •Ability to understand and provide written informed consent.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Female patients of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) test within 3 weeks prior to treatment, and must agree to use effective contraception (e.g., barrier methods) from 4 weeks prior to treatment initiation through the study duration.
排除标准
- •Patients will be deemed ineligible if they meet any of the exclusion criteria listed below.
- •Diagnosis of a malignancy other than lymphoma within the past 3 years.
- •More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.
- •Evidence of uncontrolled central nervous system involvement.
- •History of solid organ or allogeneic stem cell transplantation.
- •Uncontrolled seizures or significant psychiatric disorders.
- •Pregnancy or breastfeeding.
- •Any other serious illness or medical condition deemed inappropriate by the investigator.
- •Presence of grade ≥2 peripheral neuropathy.
- •Prior treatment with gemcitabine for lymphoma.
- •History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.
- •Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.
- •Patients currently receiving thoracic radiotherapy.
研究组 & 干预措施
Decatabine + GemOx (gemcitabine, oxaliplatin)
Experimental
干预措施: Decitabine with GemOx (Drug)
GemOx (gemcitabine, oxaliplatin)
Active Comparator
干预措施: GemOx (Drug)
结局指标
主要结局
Objective response rate
时间窗: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
The objective response rate (ORR) is defined as the proportion of patients who achieve either a complete response (CR) or a partial response (PR) to treatment, as assessed by Lugano criteria.
次要结局
- Complete response (CR) rate(From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days))
- Time to response (TTR)(From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days))
- Progression-free survival (PFS)(From cycle 1 day 1 to study completion, an average of 2 years.)
- Overall survival (OS)(From cycle 1 day 1 to study completion, an average of 2 years.)
研究者
YOUNGIL KOH
MD, PhD
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in AdultsLymphoma, LymphoblasticNCT00199017Johann Wolfgang Goethe University Hospital75
已完成
2 期
CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell LymphomaPeripheral T-Cell LymphomaNCT01806337University of Göttingen41
已完成
1 期
Bortezomib and CHOP in Patients With Advanced Stage Aggressive T Cell or Natural Killer (NK)/T Cell LymphomasPeripheral T-Cell LymphomasNon-Hodgkin LymphomaNCT00374699Samsung Medical Center55
终止
2 期
Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)Peripheral T-Cell LymphomaNCT00632827University of California, San Francisco21
已完成
2 期
Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell LymphomaLymphoma, T-Cell, PeripheralNCT01679860Fondazione IRCCS Istituto Nazionale dei Tumori, Milano92