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Comparing ICP-022 to Chlorambucil with Rituximab for treating 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)

Phase 3 Interventional Beijing InnoCare Pharma Tech Co., Ltd. · NCT04578613

This study is testing whether a new treatment called ICP-022 is better than the standard combination of Chlorambucil and Rituximab for people with untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment218 (estimated)
Ages18 Years and up
SexAll
SponsorBeijing InnoCare Pharma Tech Co., Ltd. Industry-sponsored
Drugs / interventionsrituximab
Locations56 sites (Bengbu, Anhui and 55 other locations)
Trial IDNCT04578613 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a randomized, multicenter, open-label study designed to evaluate the efficacy and safety of ICP-022 compared to the combination of Chlorambucil and Rituximab in patients with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Participants will be assessed for their response to treatment based on measurable lesions detected through imaging. The study aims to determine if ICP-022 can provide a more effective treatment option for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years and older with untreated CLL or SLL who meet specific health criteria.

Not a fit: Patients with recent strokes, hypersensitivity to study drugs, or significant cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new and potentially more effective treatment option for patients with untreated CLL/SLL.

How similar studies have performed: Other studies have shown promise in using novel therapies for CLL/SLL, but the specific approach of ICP-022 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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/Exclusion criteria may apply.

Where this trial is running

Bengbu, Anhui and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.