NCT00868608已完成2 期
A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 81
- 试验地点
- 42
- 主要终点
- Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
研究设计
- 研究类型
- Interventional
- 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
- •Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
- •Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
- •Measurable disease with adequate bone marrow function, renal and hepatic function
排除标准
- •History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- •Prior allogeneic hematopoietic stem cell transplant (HSCT).
- •Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
研究组 & 干预措施
inotuzumab ozogamicin
Experimental
inotuzumab ozogamicin
干预措施: Inotuzumab Ozogamicin (CMC-544) (Drug)
结局指标
主要结局
Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
时间窗: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to \[≤\]1.5 cm in their greatest transverse diameter \[GTD\] for nodes more than \[\>\]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as \>50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to \[≥\]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
次要结局
- Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Duration of Response in Participants With Indolent NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL(6, 12 and 24 months)
- Duration of Response in Participants With Follicular NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL(6, 12 and 24 months)
- Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL(6, 12 and 24 months)
- Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL(Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL(6, 12 and 24 months)
- Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL(Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL(6, 12 and 24 months)
- Kaplan-Meier Estimate of the OS in Participants With Follicular NHL(Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.)
- Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL(6, 12 and 24 months)
- Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)(Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit)
- Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)(Protocol reporting period: from informed consent to at least 28 days after the last dose.)
- Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)(Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.)
研究者
研究点 (42)
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