Skip to main content
OpenTrials
Completed

NCT Number: NCT05105841

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma (SLL)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center Hospital /ID# 238797, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion 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.

Treatment and study plan

Venetoclax

Drug

Oral Tablet

Other names: Venclexta, ABT-199, GDC-0199

Ibrutinib

Drug

Oral Capsule

Other names: Imbruvica

Obinutuzumab

Drug

Intravenous (IV) Infusion

Other names: GA101, Gazyva, RO5072759

Primary outcomes

  1. 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)

    Time frame: Up to Week 32

    CR rate is defined as the percentage of participants achieving a best response of CR or CRi.

  2. CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I)

    Time frame: Up to Week 56

    CR rate is defined as the percentage of participants achieving a best response of CR or CRi.

Secondary outcomes

  1. CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+G)

    Time frame: Up to Week 32

    CR rate is defined as the percentage of participants achieving a best response of CR or CRi.

  2. CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+I)

    Time frame: Up to Week 56

    CR rate is defined as the percentage of participants achieving a best response of CR or CRi.

  3. Overall response rate (ORR) as Assessed by IRC for (V+G)

    Time frame: 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.

  4. ORR as Assessed by IRC (V+I)

    Time frame: 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.

  5. ORR as Assessed by Investigator for (V+G)

    Time frame: 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.

  6. ORR Assessed by Investigator + Ibrutinib (V+I)

    Time frame: 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.

  7. Progression-Free Survival (PFS) as Assessed by IRC for (V+G)

    Time frame: 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.

  8. PFS as Assessed by IRC for (V+I)

    Time frame: 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.

  9. PFS as Assessed by Investigator for (V+G)

    Time frame: 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.

  10. PFS as Assessed by Investigator for (V+I)

    Time frame: 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.

  11. Duration of response (DOR) as Assessed by IRC for (V+G)

    Time frame: 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.

  12. DOR as Assessed by IRC for (V+I)

    Time frame: 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.

  13. DOR as Assessed by Investigator for (V+G)

    Time frame: 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.

  14. DOR as Assessed by Investigator for (V+I)

    Time frame: 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.

  15. Overall Survival (OS) for (V+G)

    Time frame: 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.

  16. OS for (V+I)

    Time frame: 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.

  17. Time to progression (TTP) as Assessed by IRC for (V+G)

    Time frame: 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.

  18. TTP as Assessed by IRC for (V+I)

    Time frame: 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.

  19. TTP as Assessed by Investigator for (V+G)

    Time frame: 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.

  20. TTP as Assessed by Investigator for (V+I)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2021
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.