KCT0003935进行中（未招募）未知
Multi-center Phase II Study of the Combination of R-CHOP (RItuximab plus cyclophosphamide, adriamycin, vincristine, and prednisolone) and Prophylactic Intrathecal Chemotherapy with Methotrexate in Patients with CD20+ Primary Breast Diffuse Large B-cell Lymphoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 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 Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •(1) Histologically confirmed CD20 positive primary breast DLBCL
- •(2) No prior chemotherapy, radiotherapy, radical mastectomy with axillary lymph node dissection
- •(3) 20 = age = 70
- •(4) Performance status (ECOG) = 2
- •(5) Cardiac ejection fraction = 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
- •(6) Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value, Bilirubin < 2 X upper normal value
- •(7) Adequate renal function: serum creatinine level < 2 mg/dL (177 µmol/L)
- •(8) Adequate BM functions: hemoglobin = 9 g/dL absolute neutrophil count (ANC) = 1,500/µL and platelet count = 75,000/µL
- •(9) A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause
- •(10) Life expectancy more than 6 months
- •(11) Informed consent
排除标准
- •(1) other subtype primary breast non-Hodgkin's lymphoma than DLBCL
- •(2) secondary breast DLBCL
- •(3) Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- •(4) Patients with a known history of HIV seropositivity or HCV (+). Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- •(5) Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •(6) Other serious illness or medical conditions
- •1) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •2) History of significant neurologic or psychiatric disorders including dementia or seizures
- •3) Active uncontrolled infection (viral, bacterial or fungal infection)
- •4) Significant COPD requiring oral steroid treatment or FEV1 < 0.8L on resting pulmonary function test
- •5) Other serious medical illnesses
- •6) congenital or acquired bleeding disorders
- •(7) Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
- •(8) Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- •(9) spine abnormality or disease no to be performed lumbar puncture and intrathecal injection
- •(10) Patients who donot provide written informed consent form
研究者
相似试验
进行中（未招募）
1 期
Phase I/II Study of AZD2014 given in combination with palbociclib on a background of fulvestrant for treatment of advanced ER + breast cancer that is locally advanced or has spread to other parts of the bodyocally advanced or metastatic estrogen receptor positive breast cancerEUCTR2015-003320-30-GBAstraZeneca AB54
进行中（未招募）
1 期
A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancerAdvanced HR+ breast cancerMedDRA version: 21.1Level: LLTClassification code: 10072737Term: Advanced breast cancer Class: 10029104CTIS2023-509511-84-00ovartis Pharma AG251
未知
不适用
A prospective multicenter study of combination of peripheral arterial disease in spine surgery and relation with perioperative complications.JPRN-UMIN000002115agoya university Graduate School of Medicine300
进行中（未招募）
2 期
ONO-7702/7703-03:NO-7702/ONO-7703 Phase2 StudyRadically unresectable BRAF V600-mutant thyroid cancerJPRN-jRCT2011200018Hirashima Yoshinori19
进行中（未招募）
不适用
Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium. - JASINT 1Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]MedDRA version: 9.1Level: LLTClassification code 10044412EUCTR2010-020620-22-ITPIERRE FABRE MEDICAMENT68