Clinical trial · Interventional
ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
A Randomized, Controlled, Open, Multicenter Phase 3 Study to Evaluate ICP-022 Versus Chlorambucil Combined With Rituximab for Primary Treatment of Chronic Lymphocytic Leukemia(CLL)/ Small Lymphocytic Lymphoma(SLL)
NCT04578613CI-TRIAL-00066920unknownPhase 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)
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Conditions
Conditions (2)
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 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorambucil | Drug | Chlorambucil | ALIAS |
| ICP-022 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICP-022
- description
- ICP-022 will be orally administered until disease progression or unacceptable toxicity.
- interventionNames
- Drug: ICP-022
- type
- ACTIVE_COMPARATOR
- label
- Chlorambucil combined with Rituximab
- description
- Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
- interventionNames
- Drug: Chlorambucil
- Drug: Rituximab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Male or female, age ≥65 years old or age \>18 years old or \<65 years old, age \>18 years old or \<65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) \> 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment) 2. Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension 3. ECOG physical strength score is 0-2. 4. Expected survival time \>6 months. 5. Voluntary written informed consent prior to screening. Key Exclusion Criteria: 1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned. 2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug. 3. Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study. 4. Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period. 5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (1)
- DERIVEDLi F, Zhou K, Xu W, Cui G, Yi S, Jin J, Zhu Z, He A, Mi J, Xia Z, Huang X, Zhou X, Yu W, Guo J, Zeng Q, Huang S, Shuang Y, Peng H, Qiu L, Xu B, Li Y, Yang Y, Zhou F, Wang Y, Liu L, Ren J, Li Y, Yang W, Gu J, Ouyang G, Hua L, Zhang J, Xiao Q, Wang S, Zhang Q, Liu J, Ding K, Zhang L, Zeng Y, Li Z, Wen Q, Gao K, Yang H, Jiang Y, Chen Y, Li Z, Tang X, Wang W, Zhao R, Qiu L, Li J. Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial. Signal Transduct Target Ther. 2026 Jul 6;11(1):261. doi: 10.1038/s41392-026-02818-x. PMID 42402625