Clinical trial · Interventional
Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation
A Phase III, Single-arm Clinical Trial of Zebutinib Combined With Immunochemotherapy With Limited Course of Treatment for Newly Treated Chronic Lymphocytic Leukemia Patients Without 17p-
NCT04980859CI-TRIAL-00052961unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zebutinib&BR or Zebutinib&FCR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zebutinib Combined With CIT arm
- description
- Zebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )
- interventionNames
- Drug: Zebutinib&BR or Zebutinib&FCR
Primary outcomes (1)
- measure
- MRD conversion rate (minimal residual disease conversion rate)
- timeFrame
- 30 days
- description
- minimal residual disease conversion rate
Secondary outcomes (2)
- measure
- OS (overall survival)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CLL patients with indications for treatment according to iwCLL; * CT/MRI shows measurable lesions; * ECOG score is 0-2; * No pregnancy plans during treatment Exclusion Criteria: * Richter transformation; * 17p-/TP53 amplification ≥20% (FISH); * Received steroids within 7 days before starting treatment; * Have previously received treatments for chronic lymphocytic leukemia; * Vaccine live attenuated vaccine within 4 weeks of randomization; * Any life-threatening disease; * Central nervous system leukemia; * Apoplexy, history of intracranial hemorrhage; * HIV or HCV or HBVpositive
References
Publications (0)
Data not yet available
No reference posted for this study.