Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGICP-022
ICP-022 at a dose of 150mg, QD
DRUGChlorambucil
0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
DRUGRituximab
375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 5 years | Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014). |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Up to 5 years |
| Duration Of Response (DOR) | Up to 5 years |
| Overall Survival (OS) | Up to 5 years |
Countries
China
Contacts
Primary ContactApril Huang
Outcome results
None listed