This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Tablet; Oral
Concord Repatriation General Hospital /ID# 201261
Concord, New South Wales, Australia
RECRUITINGSt George Hospital /ID# 206484
Kogarah, New South Wales, Australia
RECRUITINGMonash Health - Monash Medical Centre /ID# 201263
Clayton, Victoria, Australia
COMPLETEDAnhui Provincial Cancer Hospital /ID# 209458
Hefei, Anhui, China
Overall Response Rate (ORR)
ORR is the proportion of participants with an overall response (complete remission \[CR\], plus complete remission with incomplete bone marrow recovery \[CRi\], plus nodular partial remission \[nPR\], plus partial remission \[PR\]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
Time frame: Measured up to 2 years after the last participant has enrolled in the study.
Complete Response Rate (CRR)
CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria.
Time frame: Measured up to 2 years after the last participant has enrolled into the study.
Duration of Overall Response (DOR)
DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
Time frame: Measured up to 2 years after the last participant has enrolled into the study.
Progression Free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
Time frame: Measured up to 5 years after the last participant has enrolled into the study.
Event Free Survival (EFS)
EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
Time frame: Measured up to 5 years after the last participant has enrolled into the study.
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
Time frame: Measured up to 5 years after the last participant has enrolled into the study.
Time to 50% reduction in absolute lymphocyte count (ALC)
Time to 50% reduction in ALC is defined as the number of days from the date of first dose to the date when the ALC has reduced to 50% of the baseline value.
Time frame: Measured up to 2 years after the last participant has enrolled into the study.
Overall Survival (OS)
OS is defined as number of days from the date of first dose to the date of death.
Time frame: Measured up to 5 years after the last participant has enrolled into the study.
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Peking University People's Hospital /ID# 156575
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital /ID# 156579
Fuzhou, Fujian, China
RECRUITINGGuangdong Provincial Peoples Hospital /ID# 160509
Guangzhou, Guangdong, China
RECRUITINGNanfang Hospital of Southern Medical University /ID# 156571
Guangzhou, Guangdong, China
RECRUITINGThe Second Hospital of Hebei Medical University /ID# 159143
Shijiazhuang, Hebei, China
COMPLETED...and 21 more locations