NL-OMON54774招募中3 期
Efficacy of alternating immunochemotherapy consisting of RCHOP + R-HAD versus R-CHOP alone, followed by maintenance therapy consisting of additional lenalidomide with rituximab versus rituximab alone for older patients with mantle cell lymphoma - HOVON 119 MCL R2 Elderly
YSARC (The Lymphoma Academic Research Organisation)0 个研究点目标入组 75 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Randomization 1:
- •1. signed informed consent form
- •2. Biopsy-proven mantle cell lymphoma according to WHO classification,
- •including evidence of cyclin D1 overexpression or the translocation
- •t(11;14)(q13;q32),
- •3. >= 60 years of age and ineligible for autologous transplant
- •4. Ann Arbor stage II-IV
- •5. previously untreated (except for patients randomized directly for
- •maintenance treatment who will receive 8 RCHOP before registration in the trial)
- •6. ECOG performance status <= 2
- •7. Male subjects must:
- •- agree to use a condom during sexual contact with a woman of childbearing
- •potential, even if they have had a vasectomy, throughout lenalidomide therapy
- •- agree to not donate semen during lenalidomide therapy.
- •8. All subjects must:
- •- have an understanding that the lenalidomide could have a potential
- •teratogenic risk.
- •- agree to abstain from donating blood while taking lenalidomide therapy
- •- agree not to share study medication with another person.
- •- be counseled about pregnancy precautions and risks of foetal exposure.,
- •Randomization 2:
- •To be randomized for maintenance, the patient must satisfy all inclusion /
- •exclusion criteria for randomization 1 and the following criteria:
- •9. CR, CRu or PR after induction treatment, determined as per Cheson 1999
- •criteria by investigator
- •10. During the run-in period of 6 months starting from the date of the first
- •randomization, in the case of direct randomization into maintenance phase,
- •patient must have been treated in first line by 6-8 cycles of R-CHOP.
排除标准
- •Randomization 1:
- •1. Female of child-bearing potential (without natural menopause for at least 24
- •consecutive months, a hysterectomy or bilateral oophorectomy)
- •2. Any of the following laboratory abnormalities, if not related to lymphoma:
- •- Absolute neutrophils count (ANC) <1,000 /mm^3 (1.0 x 10^9/L) if not result
- •of a BM infiltration.
- •- Platelet counts < 75,000/mm^3 (75 x 10^9/L) if not result of a BM
- •infiltration.
- •- Serum aspartate transaminase (AST/SGOT) or alanine transaminase(ALT/SGPT)
- •>3.0 x upper limit of normal (ULN).
- •- Serum total bilirubin > 1.5 UNL (except if due to Gilbert*s syndrome)
- •3. Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) < 30 mL /
- •4. Central nervous system involvement by lymphoma
- •5. Contraindication for medicamentous DVT prophylaxis for patients at high risk
- •6. Prior history of malignancies other than MCL unless the subject has been
- •free of the disease for >= 5 years (Exceptions: Basal or squamous cell carcinoma
- •of the skin, Carcinoma in situ of the cervix or of the breast, Incidental
- •histologic finding of prostate cancer (TNM stage of T1a or T1b).
- •7. Any serious medical condition, laboratory abnormality, or psychiatric
- •illness that would prevent the patient to receive the study medication as
- •8. Poor cardiac function (LVEF <50%) on echocardiography
- •9. Seropositivity for human immunodeficiency virus (HIV, mandatory test)
- •Seropositivity for hepatitis C virus (HCV, mandatory test), Active viral
- •infection with hepatitis B virus (HBV, mandatory test):
- •- HBsAg positive
- •- HBsAg negative, anti-HBs positive and anti-HBc positive
- •Patients with prior Hepatitis B must be given antiviral prophylaxis and HBV DNA
- •monitored. Note: Patients who are HBsAg negative, anti-HBs positive and/or
- •anti-HBc positive but viral DNA negative are eligible.
- •10. Uncontrolled illness including, but not limited to:
- •- Active infection requiring parenteral antibiotics
- •- Uncontrolled diabetes mellitus
- •- Chronic symptomatic congestive heart failure (Class NYHA III or IV).
- •- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction
- •within 6 months
- •- Clinically significant cardiac arrhythmia that is symptomatic or requires
- •treatment, or asymptomatic sustained ventricular tachycardia.
- •11. Prior >= Grade 3 allergic hypersensitivity to thalidomide.
- •12. Prior >= Grade 3 rash or any desquamating (blistering) rash while taking
- •thalidomide.
- •13. Subjects with >= Grade 2 neuropathy.
- •14. Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to
- •murine antibodies
- •15. Prior use of lenalidomide.
- •16. Participation in another clinical trial within three weeks before
- •randomization in this study., Randomization 2:
- •The presence of any exclusion criteria of randomization 1 or of the following
- •criteria will exclude a subject from enrollment in the maintenance phase:
- •17. SD or PD after induction treatment determined as per Cheson 1999 criteria
- •assessed by investigator.
- 另有 5 项未显示
研究者
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