EUCTR2014-002654-39-NL进行中（未招募）1 期
A phase II study evaluating the effect of the addition of lenalidomide to R-CHOP for patients with newly diagnosed MYC positive DLBCL and BCL-U - HOVON 130 NH
HOVON Foundation0 个研究点目标入组 85 人开始时间: 2015年1月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
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. DLBCL or BCL-U, histologically confirmed according to the WHO classification 2008 with a MYC rearrangement as determined by FISH comprising:
- •- single hit (SH MYC+ lymphoma, not fulfilling the criteria for Burkitt Lymphoma ) or
- •- double hit lymphoma (DH) MYC+/BCL2+ or MYC+/BCL6+ or
- •- triple hit lymphoma (TH) MYC+/BCL2+/BCL6+
- •2. Age = 18 year
- •3. No prior treatment except
- •- local radiation or short course (max 7 days) steroids (max 100 mg/day)
- •- 1 course of R-CHOP in case MYC positivity became evident during first cycle of treatment
- •4. WHO performance status (PS) 0-3, status 4 only if disease related (see appendix C)
- •5. Ann Arbor stage II-IV
- •6. Measurable disease: on contract-enhanced CT scan at least 1 lesions/node with a long axis of >1.5 cm and a short axis of =1.0 cm
- •7. Negative pregnancy test at study entry
- •8. Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Risk Management Program
- •9. Written informed consent
- •10. Patient is capable of giving 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 54
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. All histopathological diagnoses other than DLBCL not otherwise specified or BCL-U according to the WHO classification 2008 (like Burkitt Lymphoma, DLBCL associated with chronic inflammation) irrespective of the presence of MYC rearrangement
- •2. Known history of indolent lymphoma, or presence of indolent lymphoma in the diagnostic lymph node. If during screening localization of an indolent lymphoma in the bone marrow biopsy is diagnosed, the patient is eligible.
- •3. Absence of contract-enhanced CT scan (neck, thorax, abdomen, pelvis) and 18F-FDG PET scan before first cycle of R-CHOP
- •4. Inadequate renal function or creatinine clearance < 30 mL/min (after rehydration)
- •5. Inadequate hepatic function: bilirubin > 3 times ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin
- •6. Inadequate hematological function: ANC < 1.0x109/L or platelets < 75x109 /L unless lymphoma related
- •7. CNS localization of the lymphoma. Liquor analysis before start of treatment is only necessary in case of suspicion
- •8. Female subject pregnant or breast-feeding
- •9. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- •10. Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If echo or MUGA is obtained the LVEF should exceed 40%
- •11. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) that would jeopardize the patient's ability to receive the regimen with reasonable safety
- •12. HIV positivity
- •13. Active Hepatitis B or C infection as defined by positive serology and transaminitis. Non-active Hepatitis B carriers may be included if protected with lamivudine
- •14. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
- •15. Severe neurological or psychiatric disease
- •16. Current participation in another clinical trial interfering with this trial
- •17. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •17. Claustrophobia to the extent that PET-CT is impossible
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