Previously Untreated CLL and SLL: Safety and Efficacy of Venetoclax in Combination with Obinutuzumab or Ibrutinib in Japanese Subjects

JRCT ID: jRCT2021210055

Registered date:26/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
• Date of first enrollment: 30/11/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Arm: Venetoclax + Obinutuzumab (V+G)
Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles.

Arm: Venetoclax + Ibrutinib (V+I)
Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles.

Outcome(s)

• Primary Outcome: 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)

Secondary Outcome

1. CR/CRi rate as assessed by investigator per 2008 iwCLL.
2. Overall response rate (ORR), defined as the proportion of subjects 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.
3. ORR, defined as the proportion of subjects with a best overall response of CR, CRi, PR or nPR per 2008 iwCLL criteria as assessed by investigator.
4. PFS, 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.
5. PFS, 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 the investigator according to iwCLL criteria.
6. Duration of response (DOR), 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.
7. Duration of response (DOR), 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 the investigator according to iwCLL criteria.
8. Overall survival (OS), defined as the time from the date of the first dose of any study drug until death due to any cause.
9. Time to progression (TTP), 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.
10. Time to progression (TTP), defined as the time from the date of first dose of any study drug until the date of disease progression, as determined by the investigator according to iwCLL criteria.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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

Exclude criteria

- Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL;
Richter's transformation or pro-lymphocyticleukemia).
- Previous treatment history for CLL/SLL.

Related Information

• Primary Sponsor: Okubo Sumiko
• Secondary ID(s): NCT05105841