Chronic Lymphocytic Leukemia: Venetoclax-Obinutuzumab Retreatment inPatients with Recurring Disease
- Conditions
- Chronic lymphocytic leukemia (CLL)MedDRA version: 21.1Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001037-39-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
•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
the study.
•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
•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
agents.
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method