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
NCT03406156Phase 3Completed
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 120 (actual)
- Start date
- 10 Aug 2018
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Jul 2023
- Last update posted
- 6 Aug 2024
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Non randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- Obinutuzumab Drug
- Bendamustine Drug
- Venetoclax Drug
Conditions and primary outcome
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
Primary outcome
Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) (From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug); Complete Remission Rate (From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03406156 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time patients were followed was: 1183.0 days (Obinutuzumab Debulking); 1185.5 days (Obinutuzumab + Bendamustine Debulking); 1114.0 days (Obinutuzumab + Venetoclax Post-debulking); and 992.5 days (Venetoclax Monotherapy Post-debulking).
| Group | Affected | At risk |
|---|---|---|
| Obinutuzumab Debulking | 7 | 84 |
| Obinutuzumab + Bendamustine Debulking | 3 | 36 |
| Obinutuzumab + Venetoclax Post-debulking | 15 | 117 |
| Venetoclax Monotherapy Post-debulking | 13 | 114 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT03406156.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03406156 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.