KCT0003034招募中未知
Multicenter phase II study of ixazomib maintenance in patients with newly diagnosed mantle cell lymphoma
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 98
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male or female patients aged =19 years
- •2. Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: determined by histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction)
- •3. Patients who can provide tumor tissue (non-chromatic tissue slides) and blood samples for genetic testing/analysis.
- •4. Stage II, III, or IV
- •5. Patients who received R-CHOP or R-bendamustine or VR-CAP induction chemotherapy within 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation. .
- •6. No clinical evidence of central nervous system (CNS) involvement by lymphoma
- •7. Patients must have measurable disease; CT scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined CT/PET scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the CT component
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •9. Absolute neutrophil count (ANC) > 1,000 mm^3 (unless low count due to marrow involvement or splenomegaly)
- •10. Platelets > 75,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
- •11. Creatinine clearance of = 30 mL/min
- •12. Total bilirubin = 1.5 x the upper limit of normal (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), alanine transaminase level =3 times the upper limit of normal; aspartate transaminase level =3 times the upper limit of normal
- •13. Female patients had to be post-menopausal for =1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for =6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.
排除标准
- •1. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- •2. Grade 2 or higher baseline peripheral neuropathy
- •3. Major surgery within 14 days before enrollment.
- •4. Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
- •5. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
- •6. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- •7. Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John’s wort.
- •8. Active systemic infection requiring treatment, a known diagnosis of human HIV, or active hepatitis B (hepatitis B carriers were permitted)
- •9. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •10. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- •11. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- •12. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •13. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
- •14. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
研究者
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