KCT0007009尚未招募未知
A randomized phase II trial comparing rituximab/bendamustine(RB) alternating with rituximab/bendamustine/cyrarabine(RBAC) with RB as induction therapy in elderly patients with newly diagnosed and transplant-ineligible mantle cell lymphoma
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 90
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
- 60?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification creiteria.
- •2. Age = 70years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.
- •3. ECOG performance status 2 or less
- •4. Adequate organ functions
- •- Adequate heart function: LVEF = 50% by echocardiography or MUGA
- •- Adequate renal function: serum creatinine = 2.0mg/dL or CrCl = 40mL/min based on the Cockcroft-Gault method.
- •- Adequate hepatic function: = 2.5 times the upper limit of ALT(= 5times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and = 2 times the upper limit of ALT (=3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)
- •Adequate hematologic function: Absolute neutrophil conuts (ANC) = 1,500/mL, platelet counts = 100,000/mL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)
- •5. Written informed consent
排除标准
- •1. In-situ mantle cell lymphoma
- •2. Ann Arbor stage 1 disease
- •3. Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years
- •4. Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,
- •5. Central nervous system involvement.
- •6. HBsAg(+) or anti-HBc Ab(+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)
- •7. History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)
- •8. Known history of human immunodeficiency virus (HIV) infection
- •9. Any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
- •- Congestive heart failure = NYHA class 3
- •- Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)
- •- History of significant neurological or psychological discorder including dementia and seizure disorder
- •- Severe chronic obstructive pulmonary disease with hypoxemia
- •Cerebrovascular disease including transient ischemic attack within the past 6 months
- •- Non-healing wound, ulcer or bone fracture
- •- Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- •10. Concomitant administrationof any other experimental durgs under investigation
- •11. Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol
- •12. Major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment.
- •13. If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers[diaphragm, cervical cap] in the patient's partner and the use of condoms in men) when sexually active.
研究者
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