EUCTR2021-001037-39-IT进行中（未招募）1 期
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy andSafety of Venetoclax-Obinutuzumab Retreatment in Patients withRecurring Chronic Lymphocytic Leukemia - na
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Adult male or female, at least 18 years old.
- •Subjects or their legally authorized representative must voluntarily sign
- •and date an informed consent, approved by an independent ethics
- •committee (IEC)/institutional review board (IRB), prior to the initiation
- •of any screening or study-specific procedures.
- •Adequate marrow function independent of growth factor or transfusion
- •support within 2 weeks of Screening as follows, unless cytopenia is due
- •to marrow involvement of CLLPreviously completed venetoclax +
- •obinutuzumab (VenG) regimen as first line fixed duration therapy and
- •achieved documented response, defined as CR, CRi, PR, or nPR.
- •Patients who will not receive approved second-line therapies as
- •assessed by the investigator and patient preference may be eligible for
- •For Cohort 1: More than 24 months between the last dose of venetoclax
- •and progression re-quiring treatment after completion of 1L VenG
- •treatment; b) for Cohort 2: 12- 24 months be-tween the last dose of
- •venetoclax and progression requiring treatment after completion of 1L
- •VenG treatment.
- •For all females of child-bearing potential; a negative serum pregnancy
- •test at the Screening Visit and a negative urine pregnancy test at Cycle 1
- •Day 1 prior to the first dose of study drug; more frequent testing is
- •acceptable if required per local regulation.
- •Female subjects of childbearing potential must practice at least 1
- •protocol-specified method of birth control, that is effective from Study
- •Day 1 through at least 30 days after the last dose of venetoclax and at
- •least 18 months after the last dose of obinutuzumab. Female subjects of
- •non-childbearing potential do not need to use birth control.
- •If male, and subject is sexually active with female partner(s) of
- •childbearing potential, he must agree, from Study Day 1 for at least 3
- •months after the last dose of obinutuzumab and/or ve-netoclax, to
- •practice the protocol-specified contraception. In addition, his female
- •partner(s) of childbearing potential must use at least one of the
- •contraceptive measures as defined.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Subject has not received an intervening treatment for CLL after
- •completing previous treatment with VenG.
- •Subject has no contraindication for all available uric acid reducing
- •Subject has not discontinued prior VenG treatment due to progressive
- •disease (PD) during treatment.
- •No active or uncontrolled autoimmune hemolytic anemia (AIHA) or
- •immune thrombocytope-nic purpura (ITP).
- •No history of clinically significant medical conditions or any other
- •reason that the investigator determines would interfere with the
- •subject's participation in this study or would make the subject an
- •unsuitable candidate to receive study drug.
- •No history of an allergic reaction or significant sensitivity to
- •constituents of the study drug (and its excipients) and/or other products
- •in the same class.
- •No positive test results for, or suspicion of, hepatitis B virus infection
- •(HBV) infection (defined as positive hepatitis B surface antibody
- •[HBsAg] serology), based on site standard practices prior to anti-CD20
- •antibody infusion and obinutuzumab prescribing information.3 Testing
- •should be conducted prior to initiation of obinutuzumab per site
- •standard of care and obinutuzumab prescribing information.
- •For subjects who show evidence of hepatitis B infection (HBsAg
- •positive [regardless of anti-body status] or HBsAg negative but anti-HBc
- •positive), consult physicians with expertise in managing hepatitis B
- •regarding monitoring and consideration for HBV antiviral therapy.
- •Subjects may be included if HBV DNA is undetectable, provided that
- •they are willing to under-go monthly DNA testing, during and for several
- •months following treatment with obinutuzumab. Subjects who have
- •protective titers of hepatitis B surface antibody (HBsAb) af-ter
- •vaccination or prior but cured hepatitis B are eligible.
- •No positive test result for hepatitis C (hepatitis C virus [HCV] antibody
- •serology testing), based on site standard practices prior to anti-CD20
- •antibody infusion and obinutuzumab prescribing information.3
- •No known active SARS-CoV-2 infection. If a subject has
- •signs/symptoms suggestive of SARS-CoV-2 infection, the subject must
- •have a negative molecular (e.g., PCR) test result. In addition, if the site considers the subject currently at risk for developing SARS-CoV-2
- •infection, then the subject should either be tested or advised to come
- •back for study screening after 14 days.
- •Subject must not have used known strong cytochrome P450 (CYP)3A
- •inhibitors or strong CYP3A inducers from 7 days prior to venetoclax
- •initiation through dose ramp-up, nor other prohibited drugs and food
- •products within 3 days prior to first dose of study drug (see Section 5.3).
- •Subject must not have received any live vaccine within 4 weeks prior to
- •the first dose of study drug or be expected need of live vaccination
- •during study participation including at least 4 weeks after the last dose
- •of venetoclax and/or after B cell recovery for obinutuzumab.
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