EUCTR2005-001100-40-DE进行中（未招募）不适用
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone plus Rituximab (CHOP-R) andCyclophosphamide, Pixantrone, Vincristine, Prednisone plus Rituximab (CPOP-R) inPatients with Diffuse Large-B-cell Lymphoma: A Phase II, Randomized,Multicenter, Comparative Trial
Cell Therapeutics Europe S.r.l.0 个研究点目标入组 280 人开始时间: 2005年11月24日最近更新:
适应症
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
- 280
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. Previously untreated and histologically confirmed diffuse large B-cell lymphoma
- •according to REAL/WHO classification. The histological specimen, i.e. lymph node
- •biopsy slides or tissue blocks, used to determine eligibility must be available for
- •2. Stage II, III or IV disease
- •4. Age = 18 years
- •5. ECOG performance status of = 2
- •6. At least one objectively bidimensionally 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.
- •7. Life expectancy = 3 months according to investigator’s opinion.
- •8. Serum bilirubin = 1.5 x the institution’s upper limit normal (ULN) and creatinine
- •=2.0 ULN and AST or ALT =2.0 x the institution’s ULN. If hepatic involvement by
- •lymphoma is present, AST or ALT may be =5.0 x the institution’s ULN.
- •9. LVEF = 50% determined by MUGA scan.
- •10. Ability to comply with the visit schedule and assessments required by the protocol.
- •11. Signed approved informed consent, with understanding of study procedures.
- •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
- •1. Any prior chemotherapy (except intrathecal chemotherapy at diagnosis and
- •pretreatment corticosteroid therapy) or radiotherapy. Patients may receive
- •corticosteroid pretreatment therapy for up to 7 days after randomization, if judged
- •appropriate by the investigator, to reduce tumor burden.
- •2. Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse
- •large B-cell.
- •3. History of indolent lymphoma
- •4. Active CNS involvement based on clinical evaluation (if the patient requires a
- •diagnostic lumbar puncture due to high risk criteria, i.e., sinus involvement, high
- •LDH, high IPI, or bone marrow involvement, intrathecal chemotherapy may be
- •administered according to institutional standards. This can include: methotrexate,
- •cytarabine and corticosteroids).
- •5. HIV-related lymphoma.
- •6. Major thoracic and/or abdominal surgery within the 4 weeks before randomization
- •from which the patient has not fully recovered except for diagnosis of NHL. Patients
- •who have had minor surgery may be enrolled after a =1 week recovery period except
- •for diagnosis of NHL.
- •7. Clinically significant cardiovascular abnormalities (equal to NYHA grade III - IV),
- •myocardial infarction within the prior 6 months, severe arrhythmia or uncontrolled
- •hypertension, history of CHF.
- •8. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep
- •seated or systemic mycotic infections.
- •9. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. Patients with
- •seropositivity presumed to be due to prior vaccination against Hepatitis B virus or
- •resolved infection will not be excluded.
- •10. 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.
- •11. Known hypersensitivity to the excipients or the study drugs that the patient will
- •12. Any contraindications to the study drugs as described in the Summary of Product
- •Characteristics or package inserts. These include but are not limited to urinary tract
- •disturbances (e.g. dysuria, any difficulty urinating) and increased bleeding affinity.
- •13. Neurological contraindication to vincristine (e.g. peripheral neuropathy).
- •14. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise
- •unsuitable.
- •15. General status that, in the opinion of the Investigator does not permit the
- •administration of eight courses of CHOP-R/CPOP-R.
- •16. Treatment with any other investigational study drug within 30 days before
- •randomization. Patient must have recovered from all side effects of other
- •investigational therapy.
- •17. Potentially fertile men and women and their sexual partners not willing to use
- •adequate contraception as defined by the Investigator during the study and for 6
- •months after the last day of study drug administration.
- •18. Any circumstance at the time of study entry that would preclude completion of the
- •study or the required follow-up.
研究者
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