Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Conditions
- Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
- Interventions
- Registration Number
- NCT05105841
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
-
Adult male or female, at least ≥ 65 years old; or 20 to 64 years old and have at least 1 of the following:
- Cumulative Illness Rating Scale (CIRS) score > 6.
- Creatinine clearance (CrCl) estimated < 70 mL/min using Cockcroft-Gault equation.
-
Must have measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 cm in longest diameter.
-
Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
- Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation or pro-lymphocytic leukemia).
- Previous treatment history for CLL/SLL.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Venetoclax + Obinutuzumab (V+G) Venetoclax Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles. Venetoclax + Obinutuzumab (V+G) Obinutuzumab Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles. Venetoclax + Ibrutinib (V+I) Venetoclax Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles. Venetoclax + Ibrutinib (V+I) Ibrutinib Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles.
- Primary Outcome Measures
Name Time Method CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I) Up to Week 56 CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
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) Up to Week 32 CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
- Secondary Outcome Measures
Name Time Method CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+G) Up to Week 32 CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+I) Up to Week 56 CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Overall response rate (ORR) as Assessed by IRC for (V+G) Up to Week 32 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.
ORR as Assessed by IRC (V+I) Up to Week 56 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.
Progression-Free Survival (PFS) as Assessed by IRC for (V+G) Up to Week 32 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.
DOR as Assessed by IRC for (V+I) Up to Week 56 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.
TTP as Assessed by Investigator for (V+I) Up to Week 56 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.
ORR as Assessed by Investigator for (V+G) Up to Week 32 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.
Duration of response (DOR) as Assessed by IRC for (V+G) Up to Week 32 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.
DOR as Assessed by Investigator for (V+G) Up to Week 32 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.
DOR as Assessed by Investigator for (V+I) Up to Week 56 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.
Overall Survival (OS) for (V+G) Up to Week 32 OS is defined as the time from the date of the first dose of any study drug until death due to any cause.
OS for (V+I) Up to Week 56 OS is defined as the time from the date of the first dose of any study drug until death due to any cause.
Time to progression (TTP) as Assessed by IRC for (V+G) Up to Week 32 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.
TTP as Assessed by IRC for (V+I) Up to Week 56 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.
ORR Assessed by Investigator + Ibrutinib (V+I) Up to Week 56 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.
TTP as Assessed by Investigator for (V+G) Up to Week 32 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.
PFS as Assessed by IRC for (V+I) Up to Week 56 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.
PFS as Assessed by Investigator for (V+G) Up to Week 32 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.
PFS as Assessed by Investigator for (V+I) Up to Week 56 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.
Trial Locations
- Locations (20)
National Cancer Center Hospital /ID# 232449
🇯🇵Chuo-ku, Tokyo, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239883
🇯🇵Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 238433
🇯🇵Sendai-shi, Miyagi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524
🇯🇵Nagoya-shi, Aichi, Japan
The Cancer Institute Hospital Of JFCR /ID# 232450
🇯🇵Koto, Tokyo, Japan
Kindai University Hospital /ID# 234001
🇯🇵Osakasayama-shi, Osaka, Japan
National Hospital Organization Shikoku Cancer Center /ID# 234059
🇯🇵Matsuyama-shi, Ehime, Japan
Hokkaido University Hospital /ID# 238377
🇯🇵Sapporo-shi, Hokkaido, Japan
Niigata University Medical & Dental Hospital /ID# 238324
🇯🇵Niigata-shi, Niigata, Japan
Duplicate_Okayama University Hospital /ID# 238467
🇯🇵Okayama-shi, Okayama, Japan
Shimane University Hospital /ID# 234076
🇯🇵Izumo-shi, Shimane, Japan
Osaka University Hospital /ID# 234037
🇯🇵Suita-shi, Osaka, Japan
Jichi Medical University Hospital /ID# 238434
🇯🇵Shimotsuke-shi, Tochigi, Japan
NHO Nagoya Medical Center /ID# 233523
🇯🇵Nagoya-shi, Aichi, Japan
Duplicate_Chiba Cancer Center /ID# 238839
🇯🇵Chiba-shi, Chiba, Japan
Aichi Cancer Center Hospital /ID# 238797
🇯🇵Nagoya-shi, Aichi, Japan
Kyushu University Hospital /ID# 238437
🇯🇵Fukuoka-shi, Fukuoka, Japan
Tokai University Hospital- Isehara Campus /ID# 238970
🇯🇵Isehara, Kanagawa, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 234082
🇯🇵Amagasaki-shi, Hyogo, Japan
Yamagata University Hospital /ID# 234032
🇯🇵Yamagata-shi, Yamagata, Japan