NCT00901615已完成1 期
A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma
Lymphoma Study Association5 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2009年1月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- Incidence of Dose Limiting Toxicities
研究概览
简要总结
The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).
详细描述
The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with one of the following B-cell Lymphoma, CD 20 positive:
- •Mantle cell, Marginal zone, follicular
- •Histological transformation from low grade to high grade
- •Diffuse large B cell
- •Aged from 18 to 70 years
- •WHO performance status 0, 1 or 2
- •Signed inform consent
- •Life expectancy of ≥ 90 days (3 months).
- •Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
- •Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
- •† A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age > 50 years and naturally amenorrhoeic for > 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.
排除标准
- •Previous treatment with immunotherapy or chemotherapy except:
- •Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
- •Rituximab alone during less than three months, if stopped more than one year before inclusion
- •Previous radiotherapy except if localized to one lymph node area
- •Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
- •Central nervous system or meningeal involvement
- •Contraindication to any drug contained in the chemotherapy regimen
- •HIV disease, active hepatitis B or C
- •Any serious active disease or co-morbid medical condition (according to investigator's decision)
- •Any of the following laboratory abnormalities :
- •Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- •Platelet count < 100,000/mm3 (100 x 109/L).
- •Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- •Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia.
- •Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min
- •Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or lactating females.
- •Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
- •Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- •Subjects with ≥ Grade 2 neuropathy.
- •Prior use of lenalidomide.
- •Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
研究组 & 干预措施
Lenalidomide and R-CHOP
Experimental
Escalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP
干预措施: Lenalidomide and R-CHOP (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities
时间窗: 42 days
次要结局
- Complete and Overall response rates after induction(at the end of third cycle of treatment (between Day 56 and Day 63))
- Progression-Free Survival and Overall survival(7 years)
- Complete response rate and Overall response rate at the end of treatment(3 months after the end of treatment)
- Duration of response(7 years)
- Collection of adverse events(6 months)
研究者
研究点 (5)
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