JPRN-jRCT2080223607已完成2 期
Japanese phase II study in untreated patients with CD20 positive B-cell non-Hodgkin's lymphoma evaluating safety of 90-minute infusion of rituximab.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. CD20 positive follicular lymphoma or diffuse large B-cell lymphoma confirmed according to WHO 2008 classification and patients can receive R-CHOP therapy.
- •2. Patients previously untreated with chemotherapy immunotherapy, immunochemotherapy, immunoradiotherapy or hematopoietic stem cell transplantation.
- •3. Life expectancy >= 6 months.
- •4. Performance status < 3 on the ECOG scale.
- •5. Patients between 20 and 80 years of age at registration.
- •6. Adequate organ function:
- •- Absolute Neutrophil Count (ANC) >= 1,500/mcl
- •- platelet count >= 100,000/mcl
- •- hemoglobin >= 8.0 g/L
- •- AST <= 3.0 x upper limit of normal
- •- ALT <= 3.0 x upper limit of normal
- •- bilirubin <= 2.0 mg/dL
- •- creatinine <= 2.0 mg/dL
- •- left ventricular ejection fraction >= 50%
- •- oxygen saturation (SpO2) >= 96%
- •7. Hospitalization. The day of rituximab administration in Cycle 1, and the day of the first rituximab 90 minutes administration.
- •8. Patients who signed a written informed consent form.
排除标准
- •1. With a history of other monoclonal antibody treatment.
- •2. Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration.
- •3. Who received G-CSF or other hematopoietic cytokine within one week prior to trial entry.
- •4. With a history of sensitive or allergic to murine-derived materials.
- •5. Having received major surgery (excluding lymph node biopsy) within 4 weeks prior to trial entry.
- •6. Tumor cells in peripheral blood > 10,000/mcl.
- •7. Positive HIV antibody.
- •8. Active hepatitis. Positive HBV serology positive (i.e., HBs antigen or HBs antibody positive), or positive HCV antibody within 4 weeks prior to trial entry.
- •9. Clinically significant heart failure, grade 3 or 4 a ventricular arrhythmia within one year prior to trial entry, or NYHA class II or greater heart failure.
- •10. Patients with infections or serious underlying medical conditions which could impair the ability of the patient to participate in the trial.
- •11. Diabetic patients who have treated with drugs.
- •12. Patients with malignant (except B-cell non-Hodgkin's lymphoma) within 2 years prior to trial entry.
- •13. Presence or history of CNS lymphoma infiltration.
- •14. Serious psychological disorders.
- •15. Pregnant or breast-feeding women.
- •16. Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter.
- •17. Patients who have participated in a study or a research of other investigational drug at screening.
- •18. In the opinion of the investigator, patients are unsuitable for any reasons.
研究者
相似试验
未知
1 期
A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of AZD2171 Alone and in Combination With AZD2171 and Pac/CarbCarcinoma, Non-Small-Cell LungJPRN-jRCT2080220478AstraZeneca
进行中（未招募）
1 期
Study to assess the value of a nuclear medicine procedure (Tc-99m tetrofosmin SPECT) to identify tumor recurrence in patients with brain tumors after radiation therapy.Patients with high grade brain tumorsMedDRA version: 20.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005573-21-HUpro-ACTINA S.A.51
进行中（未招募）
1 期
Study to assess the value of a nuclear medicine procedure (Tc-99m tetrofosmin SPECT) to identify tumor recurrence in patients with brain tumors after radiation therapy.Patients with high grade brain tumorsMedDRA version: 20.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005573-21-FRpro-ACTINA S.A.30
进行中（未招募）
1 期
Study to assess the value of a nuclear medicine procedure (Tc-99m tetrofosmin SPECT) to identify tumor recurrence in patients with brain tumors after radiation therapy.Patients with high grade brain tumorsMedDRA version: 18.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005573-21-DEpro-ACTINA S.A.30
未知
1 期
A phase 1/2 study of E6005 in Japanese patients with atopic dermatitisAtopic dermatitsJPRN-jRCT2080221229Eisai Co., Ltd.40