A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Objective Response Rate (CR + PR)
研究概览
简要总结
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
- •Is CD20 positive (by immunohistochemistry or FACS)
- •Is Cyclin D positive (by immunohistochemistry or FACS)
- •Has received prior chemotherapy (required minimum of 1 prior therapies)
- •Has received prior treatment with Rituxan
- •Has an ECOG Performance Status (PS) 0-2
- •Is greater than or equal to 18 years of age
- •Has appropriate laboratory values (please refer to protocol for specific laboratory values)
- •If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
- •Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
- •If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
- •Has signed a Patient Informed Consent Form
- •Has signed a Patient Authorization Form
排除标准
- •Has other lymphomas not classified as MCL
- •Has had prior treatment with Gemzar and/or Novantrone
- •A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
- •Has a history of hypersensitivity to murine-cell derived therapeutics
- •Has a LVEF indicative of a cardiac condition (LVEF < 50%)
- •Is receiving concurrent immunotherapy
- •Has evidence of CNS involvement
- •Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- •Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
- •Is a pregnant or nursing woman
- •Is unable to comply with requirements of study
研究组 & 干预措施
Experimental arm
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
干预措施: gemcitabine (Drug)
Experimental arm
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
干预措施: mitoxantrone (Drug)
Experimental arm
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
干预措施: rituximab (Drug)
结局指标
主要结局
Objective Response Rate (CR + PR)
时间窗: 2 years
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
次要结局
- Duration of Response(From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.)
- Overall Survival (OS) Rate at 1 Year(1 year.)
- Progression-free Survival Rate at 1 Year.(1 year.)