EUCTR2014-001620-29-ES进行中（未招募）不适用
Phase II clinical trial to evaluate the combination of lenalidomide with R-GDP (rituximab, gemcitabine, dexamethasone and cisplatin) in patients diagnosed with refractory diffuse large B-cell lymphoma not candidates for high-dose chemotherapy and hematopoietic progenitor cell transplantation
Grupo Español para el Tratamiento y Estudio de los Linfomas (GOTEL)0 个研究点目标入组 77 人开始时间: 2014年7月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 77
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
- •1. Patients over 18 years old.
- •2. Patients with diffuse large cell lymphoma (DLBCL) diagnosed by biopsy, including immunohistochemical positivity for CD20 study.
- •3. Patients with relapsed or refractory DLBCL (DLBCL r / r) after receiving at least a first line of treatment that included chemotherapy and anti-CD20 monoclonal antibodies. Biopsy recommended but not mandatory.
- •4. Patients who are not candidates for autologous hematopoietic cell transplantation according to the investigator´s criteria.
- •5. ECOG Performance Status ? 2.
- •6. Life expectancy over 3 months.
- •7. All patientsmust accept common contraception methods in clinical trials with lenalidomide.
- •8. Women of childbearing potential must have a negative pregnancy test result at screening.
- •9. Signed informed consent.
- •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 77
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who may be susceptible of autologous bone marrow transplant during the evolution of the disease according to investigator´s criteria.
- •2. Patients with inadequate renal, hepatic or haematological function, and / or showing any of the following laboratory parameters (It is not allowed the use of colony stimulating factors and other similar measures for the inclusion of patients):
- •- ANC < 1000 células/mm3
- •- Platelets < 75.000/ mm3
- •- GOT o GPT > 5 normal level
- •- Total bilirubin > 2 mg/dl o conjugated bilirubin > 0.8mg/dl, except if hemolytic anemia.
- •- Creatinine clearance < 30 ml/minute
- •3. ECOG Performance Status 3 ó 4.
- •4. Any other serious medical condition, laboratory abnormality, or psychiatric illness that hinders obtaining informed consent from the patient.
- •5. Systemic infection not solved> 2 months before starting experimental treatment despite adequate anti-infective treatment.
- •6. Pregnant or lactating women.
- •7. Rejection of contraceptive methods according to the protocol.
- •8. Patients who had received any experimental therapy within 28 days prior to inclusion in the clinical trial.
- •9. Involvement of central nervous system confirmed by cerebrospinal fluid cytology or imaging test.
- •10. Previous history of malignant disease unless the patient has been free of disease ? 3 years. The following neoplasia are excluded:
- •- Basal cell carcinoma of skin
- •- Squamous cell carcinoma of skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of breast
- •- Incidentally diagnosed prostate carcinoma (T1a or T1b)
- •11. Seropositivity for HIV, Hepatitis B or Hepatitis C
- •12. Uncontrolled intercurrent illness, such as:
- •- Active infection requiring parenteral antibiotics
- •- Uncontrolled diabetes mellitus
- •- Chronic heart failure (class III or IV NYHA)
- •- Unstable angina or angioplasty, stent or heart attack in the last 6 months
- •- Thromboembolic disease grade 3-4 in the past 6 months
- •- Prior neuropathy grade ? 2
- •13. Patients who have received any of the following treatments in the specified period prior day 1:
- •- Any chemotherapy in the previous 2 weeks
- •- Nitrosoureas in the previous 6 weeks
- •- Monoclonal antibodies in previous 8 weeks
- •- External radiotherapy in the previous 3 weeks
- •- Radioimmunoconjugates in the previous 12 weeks
研究者
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