NCT06425302进行中（未招募）2 期
A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Celgene
- 入组人数
- 95
- 试验地点
- 106
- 主要终点
- Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
- •Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
- •Stage II to IV disease.
- •Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
- •i) Bulky disease defined as:.
- •A. A nodal or extra nodal (except spleen) mass > 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than >3 cm).
- •ii) Presence of at least one of the following B symptoms:.
- •A. Fever (>38°C) of unclear etiology.
- •B. Night sweats.
- •C. Weight loss greater than 10% within the prior 6 months.
- •iii) Splenomegaly with inferior margin below the umbilical line.
- •iv) Any one of the following cytopenia due to lymphoma:.
- •A. Platelets <100,000 cells/mm3 (100 x 109/L).
- •B. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
- •C. Hemoglobin < 10g/dL (6.25 mmol/L).
- •v) Pleural or peritoneal serous effusion (irrespective of cell content).
- •vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
排除标准
- •Clinical evidence of transformed lymphoma by investigator assessment.
- •Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
- •Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Doxorubicin (Drug)
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Cyclophosphamide (Drug)
Golcadomide Dose 1 + Rituximab
Experimental
干预措施: Rituximab (Drug)
Golcadomide Dose 1 + Rituximab
Experimental
干预措施: Golcadomide (Drug)
Golcadomide Dose 2 + Rituximab
Experimental
干预措施: Golcadomide (Drug)
Golcadomide Dose 2 + Rituximab
Experimental
干预措施: Rituximab (Drug)
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Rituximab (Drug)
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Vincristine (Drug)
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Prednisone (Drug)
Rituximab + Chemotherapy
Experimental
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
干预措施: Bendamustine (Drug)
结局指标
主要结局
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
时间窗: Up to approximately 12 months from participant randomization
Golcadomide + Rituximab arms only
次要结局
- Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0(Up to 28 days after last dose)
- Duration of Response (DoR)(Up to approximately 3 years after randomization of the last participant)
- Best Overall Response (OR)(Up to approximately 12 months from participant randomization)
- Complete Response at 30 months (CR30)(At approximately 30 months from randomization)
- Complete Metabolic Response at 6 months from the randomization (CMR6)(At approximately 6 months from randomization)
- Complete Metabolic Response at 12 months from the randomization (CMR12)(At approximately 12 months from randomization)
- Progression Free Survival (PFS)(Up to approximately 3 years from randomization of last participant)
- Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0(Up to 28 days after last dose)
- Overall Survival (OS)(Up to approximately 3 years from randomization of last participant)
- Number of participants who achieve CMR as assessed by Lugano criteria 2014(Up to approximately 6 months from randomization)
研究者
研究点 (106)
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