Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
NCT04008706 · ASSURE Phase 3Completed
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 552 (actual)
- Start date
- 17 Sep 2019
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025
- Last update posted
- 1 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Non randomized
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Acalabrutinib Drug
Conditions and primary outcome
- Chronic Lymphocytic Leukemia
Primary outcome
Number of Participants With Adverse Events (AEs) (Up to safety follow-up period (about 30 days from last dose) (approximately 74 months))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04008706 (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: Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
| Group | Affected | At risk |
|---|---|---|
| Acalabrutinib TN Cohort | 152 | 310 |
| Acalabrutinib R/R Cohort | 118 | 202 |
| Acalabrutinib Prior BTKi Therapy Cohort | 12 | 40 |
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 NCT04008706.
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
- NCT04008706 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.