Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries, representing approximately 30% of all adult leukemias. There is a large difference in proportion of malignant lymphoma between the United States (US) and Japan was seen in CLL/small lymphocytic lymphoma (SLL) (Japan, 3.2%; US, 24.1%). The purpose of this study is to assess how well venetoclax works in combination with obinutuzumab (V+G, Cohort 1) or with ibrutinib (V+I, Cohort 2) in Japanese participants with previously untreated CLL/Small Lymphocytic Lymphoma (SLL). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL and SLL. Study doctors put the participants in 1 of 2 groups, called treatment arms, based on variable alternating assignment. Approximately 20 adult participants with previously untreated CLL/SLL will be enrolled in the study in approximately 20 sites in Japan. Participants in group 1 will receive oral venetoclax + intravenous (IV) obinutuzumab (V+G) in 28-day cycles for a total of 12 cycles, and participants in group 2 will receive oral venetoclax + oral ibrutinib (V+I) in 28-day cycles for a total of 15 cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Duplicate_NHO Nagoya Medical Center /ID# 233523
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 238797
Nagoya, Aichi-ken, Japan
Duplicate_Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524
Nagoya, Aichi-ken, Japan
Duplicate_Chiba Cancer Center /ID# 238839
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 234059
Matsuyama, Ehime, Japan
Kyushu University Hospital /ID# 238437
Fukuoka, Fukuoka, Japan
Duplicate_Hokkaido University Hospital /ID# 238377
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 234082
Amagasaki-shi, Hyōgo, Japan
Tokai University Hospital /ID# 238970
Isehara, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239883
Kyoto, Kyoto, Japan
...and 10 more locations
Complete Remission (CR) with an Incomplete Marrow Recovery (CRi) Rate, as Assessed by an Independent Review Committee (IRC) per Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for Venetoclax + Obinutuzumab (V+G)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Time frame: Up to Week 32
CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Time frame: Up to Week 56
CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+G)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Time frame: Up to Week 32
CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+I)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Time frame: Up to Week 56
Overall response rate (ORR) as Assessed by IRC for (V+G)
ORR is defined as the proportion of participants with a best overall response of CR, CRi, partial remission (PR) or nodular partial remission (nPR) per 2008 iwCLL criteria as assessed by an IRC.
Time frame: Up to Week 32
ORR as Assessed by IRC (V+I)
ORR is defined as the proportion of participants with a best overall response of CR, CRi, partial remission (PR) or nodular partial remission (nPR) per 2008 iwCLL criteria as assessed by an IRC.
Time frame: Up to Week 56
ORR as Assessed by Investigator for (V+G)
ORR is defined as the proportion of participants with a best overall response of CR, CRi, partial remission (PR) or nodular partial remission (nPR) per 2008 iwCLL criteria as assessed by an investigator.
Time frame: Up to Week 32
ORR Assessed by Investigator + Ibrutinib (V+I)
ORR is defined as the proportion of participants with a best overall response of CR, CRi, partial remission (PR) or nodular partial remission (nPR) per 2008 iwCLL criteria as assessed by an investigator.
Time frame: Up to Week 56
Progression-Free Survival (PFS) as Assessed by IRC for (V+G)
PFS is defined as the time from the date of first dose of any study drug until the date of disease progression or death due to any cause, whichever occurs first, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 32
PFS as Assessed by IRC for (V+I)
PFS is defined as the time from the date of first dose of any study drug until the date of disease progression or death due to any cause, whichever occurs first, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 56
PFS as Assessed by Investigator for (V+G)
PFS is defined as the time from the date of first dose of any study drug until the date of disease progression or death due to any cause, whichever occurs first, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 32
PFS as Assessed by Investigator for (V+I)
PFS is defined as the time from the date of first dose of any study drug until the date of disease progression or death due to any cause, whichever occurs first, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 56
Duration of response (DOR) as Assessed by IRC for (V+G)
DOR is defined as the time from the first occurrence of overall response (CR, CRi, PR or nPR) until disease progression or death due to any cause, whichever occurs first, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 32
DOR as Assessed by IRC for (V+I)
DOR is defined as the time from the first occurrence of overall response (CR, CRi, PR or nPR) until disease progression or death due to any cause, whichever occurs first, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 56
DOR as Assessed by Investigator for (V+G)
DOR is defined as the time from the first occurrence of overall response (CR, CRi, PR or nPR) until disease progression or death due to any cause, whichever occurs first, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 32
DOR as Assessed by Investigator for (V+I)
DOR is defined as the time from the first occurrence of overall response (CR, CRi, PR or nPR) until disease progression or death due to any cause, whichever occurs first, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 56
Overall Survival (OS) for (V+G)
OS is defined as the time from the date of the first dose of any study drug until death due to any cause.
Time frame: Up to Week 32
OS for (V+I)
OS is defined as the time from the date of the first dose of any study drug until death due to any cause.
Time frame: Up to Week 56
Time to progression (TTP) as Assessed by IRC for (V+G)
TTP is defined as the time from the date of first dose of any study drug until the date of disease progression, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 32
TTP as Assessed by IRC for (V+I)
TTP is defined as the time from the date of first dose of any study drug until the date of disease progression, as determined by an IRC according to iwCLL criteria.
Time frame: Up to Week 56
TTP as Assessed by Investigator for (V+G)
TTP is defined as the time from the date of first dose of any study drug until the date of disease progression, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 32
TTP as Assessed by Investigator for (V+I)
TTP is defined as the time from the date of first dose of any study drug until the date of disease progression, as determined by an investigator according to iwCLL criteria.
Time frame: Up to Week 56
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