NCT00688883已完成2 期
A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma
Genzyme, a Sanofi Company0 个研究点目标入组 52 人开始时间: 2003年2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
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Best overall response rate; Antitumor effect
研究概览
简要总结
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
详细描述
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
- •Patients with measurable lesions (major axis > 1.5 cm by CT)
- •Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
- •Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
- •Patients who have PS Grade 0 to 2 in the criteria of ECOG
- •Patients with adequately maintained organ functions
排除标准
- •Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
- •Patients who are positive for HBs antigen, HCV antibody or HIV antibody
- •Patients who received G-CSF or blood transfusion within 1 week before the screening test
- •Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
- •Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
研究组 & 干预措施
Arm 1
Experimental
干预措施: Fludarabine Phosphate (Fludara) (Drug)
结局指标
主要结局
Best overall response rate; Antitumor effect
时间窗: at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle
次要结局
- CR rate(after last observation of last treatment cycle)
- Time to treatment failure(after last observation of last treatment cycle)
- Overall survival(after last observation of last treatment cycle)
- Adverse events collection(after last observation of last treatment cycle)
研究者
相似试验
终止
2 期
Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas.Lymphoma, Non-HodgkinNCT00354822A.O. Ospedale Papa Giovanni XXIII25
已完成
2 期
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHLLymphoma, Low-GradeNCT00311129Genzyme, a Sanofi Company41
已完成
3 期
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to EtanerceptPsoriasisNCT00527072Centocor Ortho Biotech Services, L.L.C.217
Unknown
2 期
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian CancerOvarian CancerNCT03335241Sun Yat-sen University140
Unknown
2 期
Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+GoserelinBreast NeoplasmsNCT05004142Ahon Pharmaceutical Co., Ltd.70