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A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination with Obinutuzumab or Ibrutinib in Japanese Subjects with Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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

Okubo Sumiko

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact for

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

Nov. 15, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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-lymphocyticleukemia).
- Previous treatment history for CLL/SLL.

Both

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

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.

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)

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.

+81-23-628-5840

Oct. 05, 2021

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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