NL-OMON44081已完成3 期
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapy - HOVON 121 CLLM1/GCLLSG
HOVO0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Must understand and voluntarily sign an informed consent form.
- •2. Age >= 18 years at the time of signing the informed consent form.
- •3. Must be able to adhere to the study visit schedule and other protocol
- •requirements.
- •4. Must have a documented diagnosis of CLL (IWCLL guidelines for the
- •diagnosis and treatment of chronic lymphocytic leukemia1).
- •5. Must have been treated with one of the first line induction therapies:
- •fludarabine/cyclophosphamide/rituximab, or bendamustine/rituximab or
- •fludarabine/rituximab or fludarabine/cyclophosphamide,(in case of
- •hypersensitivity reactions to Rituximab).
- •6. Must have achieved a response of at least PR (IWCLL guidelines for the
- •diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008])
- •following completion (minimum 4 cycles) of first-line induction therapy prior
- •to randomization (documentation of response status must be available).
- •and have either:
- •a. MRD levels in the peripheral blood at final restaging of >=10^2 or
- •b. MRD levels in the peripheral blood >=10^4 - <10^2 combined with at
- •least one of the following factors:
- •an unmutated IGHV-status
- •17p-deletion or
- •TP53 mutation1
- •7. Must have completed last cycle of at least 4 cycles of first-line induction
- •no less than 8 weeks (56 days) and no greater than 20 weeks (140 days)
- •prior to randomization.
- •8. Subjects who completed first line induction treatment with less than 6
- •but at least 4 cycles should document reason for early discontinuation
- •9. Must have an Eastern Cooperative Oncology Group (ECOG)
- •performance status score of <=2.
- •10. Negative serological Hepatitis B test, negative testing of Hepatitis C
- •RNA, negative HIV test within 6 weeks prior to randomization.
- •11. Females of childbearing potential (FCBP)*
- •Have two negative medically supervised pregnancy tests prior
- •to starting of study therapy. She must agree to ongoing pregnancy
- •testing during the course of the study, and after end of study therapy.
- •This applies even if the subject practices complete and continued
- •sexual abstinence.
- •Either commit to continued abstinence from heterosexual
- •intercourse (which must be reviewed on a monthly basis) or agree to
- •use, and be able to comply with, two reliable forms of effective
- •contraception simultaneously to achieve a PEARL-Index <1 without
- •interruption (Highly effective methods: Intrauterine device (IUD),
- •Hormonal (birth control pills, injections, implants), Tubal ligation,
- •Partner*s vasectomy, Additional effective methods: Male condom,
- •Definition: This protocol defines a female of childbearing potential as a sexually mature woman who: 1) has not undergone a hysterectomy or
- •bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing
- •potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- •CLL M1 Page 8 of 101
- •CLLM1 Protocol of the DCLLSG version 2.1of 4th June 2012 University of Cologne
- •Diaphragm, Cervical Cap), 28 days prior to starting study drug, during
- •the study therapy (including dose interruptions), and for 28 days after
- 另有 4 项未显示
排除标准
- •1. A CIRS Score of more than 6 or a single score of 4 for an organ system limiting the ability to receive an intensive therapy for CLL
- •2. Active infections requiring systemic antibiotics.
- •3. Systemic infection CTC grade 3 or 4 that has not resolved > 2 months prior to randomization in spite of adequate anti-infective therapy.
- •4. Autologous or allogeneic bone marrow transplant as first line therapy.
- •5. Pregnant or lactating females.
- •6. Systemic treatment for CLL in the interval between completing the last cycle of first-line induction therapy and randomization.
- •7. Participation in any clinical study or having taken any investigational therapy which would interfere with the study drug for a disease other than CLL within 28 days prior to initiating maintenance therapy.
- •8. Known presence of alcohol and/or drug abuse.
- •9. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
- •10. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for >=5 years. Exceptions include the folowing:
- •- Basal cell carcinoma of the skin
- •- Squamous cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of the breast
- •- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •11. History of renal failure requiring dialysis.
- •12. Prior therapy with lenalidomide.
- •13. Any of the following laboratory abnormalities:
- •Calculated (method of Cockroft-Gault) creatinine clearance of <60 mL/min
- •Absolute neutrophil count (ANC) < 1,000/µL (1.0 X 109/L)
- •Platelet count < 50,000/µL (50 X 109/L)
- •Serum aspartate aminotransferase (AST)/serum glutamicoxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum
- •glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
- •Serum total bilirubin > 2.0 mg/dL (with the exception of Gilbert*s Syndrome)
- •14. Uncontrolled hyperthyroidism or hypothyroidism
- •15. Venous thromboembolism within one year
- •16. >= Grade-2 neuropathy
- •17. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- •18. Disease transformation (active) (i.e. Richter*s Syndrome, prolymphocytic leukemia)
- •19. Known allergy to allopurinol, if the subject has bulky disease
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