EUCTR2020-000354-10-DE进行中（未招募）1 期
A PHASE 1/2, MULTICENTER, OPEN-LABEL STUDY TO ASSESS SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF CC-220, ALONE AND IN COMBINATION WITH AN ANTI-CD20 MONOCLONAL ANTIBODY (MAB) IN SUBJECTS WITH RELAPSED OR REFRACTORY LYMPHOMAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •1. Is = 18 years of age at the time of signing the informed consent form (ICF).
- •2. Has histologically confirmed (per local evaluation) diagnosis of lymphoma according to 2016 WHO classification including:
- •a. Cohort A and Cohort D: all subtypes including B-cell, T-cell and NK-cell NHL, and cHL.
- •b. Cohort B: all B-cell NHL.
- •c. Cohort C: FL Grade 1-3a and MZL.
- •d. Cohort D: aggressive B-cell lymphoma and FL grade 1-3a
- •e. Cohort E: aggressive B-cell lymphoma, Grade 3b FL and PMBCL.
- •f. Cohorts F and G: FL Grade 1 to 3a .
- •3. Relapsed or refractory disease according to the following definitions:
- •a. Aggressive B-cell lymphoma including transformed indolent NHLs to
- •aggressive B-cell lymphoma: after at least 2 prior lines of therapy one of
- •which must include an anti-CD20 monoclonal antibody and anthracycline
- •containing regimen.
- •b. FL and MZL: following at least 2 prior lines of systemic therapy (being previously exposed to at least 1 anti-CD20 mAb and 1 alkylating agent).
- •c. MCL: following at least 2 prior lines of therapy including at least 1 immunochemotherapy and 1 BTK inhibitor.
- •d. PTCL: following at least 2 prior lines of therapy OR after 1 prior line of standard therapy and being not eligible for any other approved regimen.
- •e. cHL: following at least 2 prior systemic lines of therapy and previously exposed to brentuximab vedotin and anti-PD1.
- •f. All other subtypes: following at least 2 prior lines of therapy.
- •g. Subjects previously treated with CAR-T therapy can be enrolled (irrespective of the indication).
- •4. Subjects must not be eligible for any other approved treatment for
- •their underlying lymphoma as assessed by the Investigator
- •5. Must have measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014). Site of measurable disease cannot be previously irradiated.
- •6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- •7. Must have the following laboratory values:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L or = 1.0 x 109/L
- •b. Hemoglobin (Hb) = 8 g/dL.
- •c. Platelets (Plt) = 75 x 109/L or = 50 x 109/L
- •d. Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvic transaminase (ALT/SGPT) = 2.5 x ULN.
- •e. Serum total bilirubin = 1.5 ULN except in cases of Gilbert’s syndrome, then = 3.0 ULN.
- •f. Estimated serum creatinine clearance of = 50 mL/min.
- •8. All subjects must:
- •a. Have an understanding that the study drug could have a potential teratogenic risk.
- •b. Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
- •9. Females of childbearing potential (FCBP1) must have 2 negative pregnancy tests as verified by the Investigator prior to starting study treatment and must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.
- •10. Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 year
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •1. Any significant medical condition, active infection (including SARSCoV-
- •2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •- A patient who is excluded for SARS-CoV-2 infection could be rescreened.
- •- In the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on Investigator assessment in consultation with the clinical trial physician, there are no sequelae that
- •would place the participant at a higher risk receiving investigational treatment.
- •- Additionally, a patient who is currently in another interventional trial for Coronavirus infectious disease 2019 (COVID-19) may not participate in the clinical trial until the protocol-specific washout period is achieved.
- •- Testing to exclude asymptomatic SARS-CoV-2 prior to enrollment should follow local standard practice.
- •2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •3. Life expectancy = 3 months.
- •4. Diagnosis of lymphoblastic lymphoma.
- •5. Aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).
- •6. Prior Grade 3 or 4 infusion related reaction with rituximab (for Cohorts B, E and F) or obinutuzumab (for Cohorts C and G).
- •7. Prior therapy with the cereblon-modulating drug CC-99282.
- •8. Chronic systemic immunosuppressive therapy or corticosteroids.
- •9. Prior ASCT = 3 months prior to starting CC-220 or > 3 months AND with unresolved, Grade > 1, treatment-related toxicity.
- •10. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning = 6 months prior to starting CC-220 or > 6 months with unresolved, Grade > 1, treatment-related toxicity.
- •11. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or obinutuzumab.
- •12. Known allergy to thalidomide, pomalidomide or lenalidomide.
- •13. Inability or unwilling to undergo protocol required thromboembolism prophylaxis.
- •14. Major surgery = 2 weeks prior to starting CC-220.
- •15. Peripheral neuropathy = Grade 2 (NCI CTCAE v5.0).
- •16. Documented or suspected CNS involvement of disease.
- •17. Subject with clinically significant cardiac disease.
- •18. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
- •19. Known chronic active hepatitis B.
- •20. History of other malignancy, unless the subject has been free of the disease for = 3 years; exceptions to the = 3-year time limit include history of incidental histologic finding of prostate cancer or prostate cancer that has been treated with curative intent.
- •21. Subject received live attenuated vaccines or live COVID-19 vaccines within 30 days prior to initiation of study treatment.
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