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临床试验/NL-OMON56451
NL-OMON56451已完成不适用

A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination with Obinutuzumab (GA101) in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin*s Lymphoma - Celgene CC-122-NHL-001

Celgene Corporation0 个研究点目标入组 25 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. >= 18 years of age or older at the time of signing the informed consent
  • •document., Entry Criteria Specific for Dose-Escalation Phase (Part A)
  • •2. Subjects with CD20 positive, histologically or cytologically-confirmed,
  • •DLBCL (including transformed low grade lymphoma) who have relapsed or
  • •refractory disease following at least two prior standard treatment regimens
  • •(eg, R-CHOP or similar first-line regimen and at least one second-line salvage
  • •regimen) and/or ASCT in chemotherapy sensitive patients (see Protocol Section
  • •7.2 for exceptions). , 3. Subjects with CD20 positive, histologically confirmed
  • •(by WHO 2008 classification [Jaffe, 2009]), FL (Grade 1, 2, or 3a) or MZL who
  • •have relapsed or refractory disease following at least one prior standard
  • •systemic treatment regimen including systemic chemo-, immune-, or
  • •chemoimmunotherapy., Entry Criteria Specific for Dose-Expansion Phase (Part B):
  • •4.Subjects with CD20 positive, histologically confirmed FL (Grade 1, 2, or 3a)
  • •who have relapsed or refractory disease following at least one prior standard
  • •systemic treatment regimen including systemic chemo-, immune-, or
  • •chemoimmunotherapy., Lenalidomide naïve
  • •a. Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) following at
  • •least one prior standard systemic treatment regimen including systemic chemo-,
  • •immune-, or chemoimmunotherapy with no prior exposure to lenalidomide (FL-1
  • •cohort). In addition, subjects must have received one prior line of salvage
  • •therapy, unless ineligible for autologous transplant.
  • •Lenalidomide exposed
  • •b. Relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a) previously
  • •treated with at least two cycles of lenalidomide-containing regimen (FL-2
  • •cohort), either as a single agent or in combination, and experienced outcomes
  • •to the lenalidomide treatment as follows:
  • •- Early relapse after lenalidomide treatment
  • •-Early progression after lenalidomide treatment
  • •-Disease refractory to lenalidomide
  • •- Lenalidomide or lenalidomide - containing regimen does not need to be the
  • •immediate prior regimen received by the subject to be eligible for entry.,
  • •Entry Criteria that apply to both Part A and Part B
  • •5. Bi-dimensionally measurable disease with at least one lesion > 1.5 cm in the
  • •transverse diameter.
  • •- Measurable disease cannot be previously irradiated. , 6. ECOG PS of 0 to 1.
  • •, 7. Subjects must have the following laboratory values at screening:
  • •Absolute Neutrophil Count (ANC) >= 1.5 x 10*9/L without growth factor support
  • •for 7 days (14 days if subject received pegfilgrastim).
  • •Hemoglobin (Hgb) >= 8 g/dL.
  • •Platelets (plt) >= 50 x 10*9/L without transfusion for 7 days.
  • •Potassium within normal limits or corrected with supplements.
  • •AST/SGOT and ALT/SGPT <= 2.5 x Upper Limit of Normal (ULN) or <= 5.0 x ULN if
  • •liver tumor is present.
  • •Serum bilirubin <=1.5 x ULN except in cases of Gilberts Syndrome, then <= 2.0
  • •Estimated serum creatinine clearance of >= 60 mL/min using the Cockcroft-Gault

排除标准

  • •1. Prior ASCT <= 3 months before first dose.
  • •2. Prior allogeneic stem cell transplant with either standard or reduced
  • •intensity conditioning.
  • •3. Prior systemic cancer-directed treatments or investigational modalities <= 5
  • •half lives or 1 month prior to starting study drugs, whichever is shorter.
  • •4. Prior radiotherapy within 1 month prior to starting study drugs.
  • •5. A major surgery <= 2 weeks prior to starting study drugs. Subjects must have
  • •recovered from any effects of recent surgery or therapy that might confound the
  • •safety evaluation of study drug.
  • •6. Prior treatment with CC-122 or obinutuzumab (GA101).
  • •7. History of severe allergic or anaphylactic reactions to humanized monoclonal
  • •antibodies.
  • •a. Allergic to any excipients in obinutuzumab.
  • •8. Treatment-related myelodysplastic syndrome.
  • •9. Prior history of secondary malignancies (except for basal cell or squamous
  • •cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless
  • •the subject has been free of the disease for >= 1 year prior to starting study
  • •10. Prior immunization with live virus vaccines (within 3 months prior to
  • •starting study drug) or anticipated immunization with live virus vaccines
  • •during the duration of the study.

研究者

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