KCT0004946尚未招募未知
Phase II study of lenalidomide/rituximab maintenance for transplatation ineligible patients with primary CNS diffuse large B-cell lymphoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 30
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
- o Limit 至 o Limit（—）
- 性别
- All
入选标准
- •1. A person who has been diagnosed with histopathologically as a primary central nervous system lymphoma and has reached a complete or partial response after standard anticancer treatment for induction purposes for primary central nervous system lymphoma.
- •2. A person who is unable to transplant autologous hematopoietic stem cells for the following reasons:
- •A. If the patient's age is 65 years or older, or if the systemic condition is determined to be weak before high-dose chemotherapy
- •B. Refusing autologous hematopoietic stem cell transplantation after high-dose chemotherapy
- •3. Proper functional condition of bone marrow, kidney, liver
- •A. Absolute neutrophil count =1000 / µL
- •B. Platelets = 50,000 / µL
- •C. Red blood cells = 9.0 g / dL
- •(Test values after correction through transfusion, hematopoietic accelerator are also possible.)
- •D. Serum calcium = 12.0 mg / dL
- •E. Serum creatinine = 1.5 x upper limit of normal (Cleaning rate of creatinine = 50 mL / min
- •(Based on Cockcroft-Gault formula)
- •F. AST / ALT = 2.5 X normal upper limit G. Total bilirubin =1.5 x normal upper limit
- •4. In the case of healthy hepatitis B carriers, participation is possible only if preventive antiviral treatment can be combined.
- •5. ECOG PS 0-2
- •6. Those who can be orally administered
- •7. Non-fertile female patients who:-Natural menopause or hysterectomy for at least 24 months prior to study enrollment,
- •or Bilateral ovarian resection
- •8. Male patients who are surgically infertile (ie, undergoing arthrotomy) who can:
- •-Males should use effective contraception during the trial period and for 4 weeks after completion of medication.
- •-For male patients, if the partner is a woman of childbearing potential and does not use the appropriate contraceptive method (even if the male patient has undergone a total resection), during the administration of the study drug, during the suspension of the dose, and for 4 weeks after completion of the dosing You should use condoms.
- •-Male patients should not donate semen for 4 weeks after or during discontinuation of the study drug, and immediately inform the investigator if the partner becomes pregnant while taking the study drug or immediately after discontinuation of the study drug.
- •-Lenalidomide risk management plan must be followed
- •9. Patients who voluntarily agreed to participate in this trial and signed a consent form
排除标准
- •Patients who meet any of the following conditions cannot participate in this clinical trial.
- •1. When transplantation is planned after chemotherapy
- •2. Patients predicting significant risk from symptomatic or uncontrolled angina and congestive heart failure, arrhythmia requiring medication, and clinically significant myocardial infarction that occurred within 6 months prior to participation in this trial.
- •3. In case of infection in progress exceeding grade 2 according to the 4.03 version of the common term of adverse reactions4. Severe, uncontrolled accompanying disease
- •5. If the patient has uncontrolled active hepatitis B or C
- •(healthy hepatitis B carriers who can be controlled by prophylactic antiviral medication)
- •6. Human immunodeficiency virus infection
- •7. Those who cannot be orally administered
- •8. Patients with a history of malignancy other than the target disease except for the following cases
- •-If the patient has not been treated for the tumor for at least 5 years or is disease-free
- •-At least 1 year has elapsed since complete resection of basal cell / squamous cell cancer or successful treatment of cervical epithelial cancer
- •9. Adverse reactions within 30 days prior to the start of screening Severe gastrointestinal bleeding that exceeds Grade 2 according to the Common Terminology 4.03 version criteria.
- •10. Thrombosis or embolism within 6 months prior to the start of screening
- •11. Patients with hypersensitivity to this drug and other components of this drug
- •(eg, angioedema, Stevens-Jones syndrome, addictive epidermal necrosis, etc.)
- •12. Patients with seizure disorders requiring medication
- •13. Patients have a substance abuse, medical, mental or social disorder that may interfere with the patient's participation
- •in the trial or in evaluating the outcome of the trial.
- •14. Women of childbearing potential
- •-Has not undergone hysterectomy or bilateral ovarian resection, or has not reached spontaneous menopause
- •(amenorrhea after chemotherapy is not excluded from childbearing status) for at least 24 consecutive months
- •(ie, menstruation at any time within the previous 24 months).
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