EUCTR2007-007698-22-FR进行中（未招募）1 期
A PHASE IB/II STUDY OF ESCALATING DOSES OF REVLIMID IN ASSOCIATION WITH R-CHOP (R2-CHOP) IN THE TREATMENT OF B-CELL LYMPHOMA - R2-CHOP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GELARC
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Phase IB: Patients with one of the following B-cell Lymphoma, CD 20 positive:
- •oMantle cell, Marginal zone, follicular
- •oHistological transformation from low grade to high grade
- •oDiffuse large B cell
- •Phase II: Patients with follicular lymphoma, WHO grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment:
- •oBulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter
- •oB symptoms
- •oElevated serum LDH or beta 2-microglobulin
- •oInvolvement of at least 3 nodal sites (each >3cm)
- •oSymptomatic spleen enlargement
- •oCompressive syndrome
- •oPleural or peritoneal effusion
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment with immunotherapy or chemotherapy except:
- •oChlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
- •oRituximab 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.
- •oAbsolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- •oPlatelet count < 100,000/mm3 (60 x 109/L).
- •oSerum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- •oSerum 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.
研究者
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