EUCTR2014-005069-60-AT进行中（未招募）1 期
R-CPOP as first line therapy for elderly patients with DLBCL and for patients with limited cardiac function with DLBCL - Pix in DLBCL first line
Medical Center - University of Freiburg0 个研究点目标入组 60 人开始时间: 2017年2月22日最近更新:
适应症
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
- 60
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. Written informed consent obtained according to international guidelines and local laws
- •2. Male or female patients aged = 18 years without upper age limit
- •3. Previously untreated and histologically confirmed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3B according to REAL/WHO classification
- •4. At least one objectively bi-dimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion; patients with the following sites of disease are NOT eligible:
- •- Patients with only skin lesions or only palpable lymph nodes
- •- Patients with spleen or bone marrow as only site of disease
- •5. Life expectancy = 3 months according to investigator´s opinion
- •6. Ann Arbor stage: II-IV
- •7. Ability to understand the nature of the trial and the trial-related procedures and to comply with them
- •8. Criteria for stratification:
- •Population 1:
- •Age = 75 years (without limited cardiac function) not eligible for standard R-CHOP 21 treatment
- •Population 2:
- •Impaired cardiac function, characterised by:
- •First 10 patients:
- •Ejection fraction: = 40% and = 50%
- •Additional patients:
- •Ejection fraction: > 30% and = 50%
- •Note: Patients = 75 years of age with impaired cardiac function are eligible for population 2.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Severe pulmonary, hepatic or renal comorbidities which make the patient ineligible for cytotoxic drug treatment
- •2. Severe cardiac impairment, e.g. NYHA class IV, (with the exception of inclusion criterion 8), or resting cardiac troponin T levels >0.05 ng/ml (according to > grade 1 CTCAE 3.0) which makes the patient ineligible for cytotoxic drug treatment
- •3. Prior treatment for lymphoma other than pre-treatment with steroids
- •4. History of indolent lymphoma
- •5. Manifestation of DLBCL disease in central nervous system (CNS)
- •6. Active hepatitis B or C, serologic positivity for HIV infection
- •7. HIV-related lymphoma
- •8. Immunisation with live virus vaccines within the last 14 days
- •9. Major thoracic and/or abdominal surgery within the 4 weeks before trial registration from which the patient has not fully recovered except for diagnosis of non-Hodgkin lymphoma (NHL); patients who have had minor surgery may be enrolled after a = 1 week recovery period except for diagnosis of NHL
- •10. Serious (NCI CTCAE grade 3-4) intercurrent infection at the time of trial registration or deep-seated or systemic mycotic infection.
- •11. Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix; patients who have been in remission from another previous malignancy for > 5 years will be considered eligible
- •12. Known hypersensitivity to pixantrone, or any drugs or excipients of the associated chemotherapy R-CPOP that the patient will receive
- •13. Simultaneous participation in other interventional trials and/or participation before the end of a required restriction period
- •14. Participation in a clinical trial within the last 30 days before being registered in this trial
- •15. Known or persistent abuse of medication, drugs or alcohol
- •16. Person who is in a relationship of dependence/employment with the sponsor or the investigator
- •17. For female patients of child-bearing potential: current or planned pregnancy, nursing period
- •18. Unwillingness to use an adequate contraception method during chemotherapy treatment until six months thereafter:
- •for male patients (unless vasectomised):
- •18.1 a latex condom during sexual contact with females of childbearing potential
- •for female patients of child-bearing potential:
- •18.2 mechanical method (female condom, diaphragm or coil) used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
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