ACTRN12613000106730已完成2 期
A Phase 2 Study of patients treated for relapsed Follicular Lymphoma: with Revlimid (Registered Trademark) consolidation added to Rituximab maintenance therapy in those remaining Positron Emission Tomography (PET) positive
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 37 人开始时间: 2013年1月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Relapsed follicular lymphoma having obtained conventional Stable disease (SD), Partial Response (PR), Complete remission unconfirmed (CRu) or Complete Remission (CR) after most recent reinduction therapy. Response assessment within 4-6 weeks of day 1 of last chemotherapy cycle.
- •Relapsed disease must be either Stage III or IV, or Stage II bulky disease defined as a tumor diameter of greater than or equal to 7 cm.
- •Symptomatic disease in need of systemic immunochemotherapy treatment as defined by the investigator.
- •Patient has provided written informed consent
- •Life expectancy at least 6 months
- •An Eastern Co-operative Oncology Group (ECOG) performance status score of less than or equal to 2 at Screening
排除标准
- •Patients with demonstrated histological transformation
- •Patients who have:
- •>6 prior cycles of Fludarabine
- •Allogeneic transplant
- •Prior exposure to Lenalidomide
- •Patients who have had a negative PET scan during re-induction therapy
- •Patients with poor haemopoeitic recovery 4-8 weeks post chemotherapy
- •Patients with inadequate liver function
- •Patients with severe renal impairment
- •Medial contraindication to rituximab
- •CNS involvement with lymphoma
- •Any uncontrolled inter-current illness
- •HIV, Hepatitis B or Hepatitis C infection
- •Pregnant or breastfeeding women
- •Prior malignancy, other than FL, unless free from disease / treatment for greater than or equal to 5 years. Exceptions include localised non-melanoma skin cancer and carcinoma in situ., and prostate cancer TNM Stage T1a or T1b
- •Patients at high risk of venous thromboembolism who are not willing to take prophylaxis
- •Patients with any psychiatric , social or geographic circumstance that would preclude protocol compliance
研究者
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