Trials / Completed
CompletedNCT03406156
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
Detailed description
Safety and efficacy data through 13 October 2021 are included in the interim analysis, which was conducted after all participants completed the post-treatment Week 65 visit or discontinued from the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obinutuzumab | Administered via intravenous infusion |
| DRUG | Bendamustine | Administered via intravenous infusion |
| DRUG | Venetoclax | The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Venetoclax was continued for a total duration of up to 53 weeks, including the 5-week ramp-up schedule. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. |
Timeline
- Start date
- 2018-08-10
- Primary completion
- 2021-10-12
- Completion
- 2023-07-12
- First posted
- 2018-01-23
- Last updated
- 2024-08-06
- Results posted
- 2022-11-03
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03406156. Inclusion in this directory is not an endorsement.