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Combining ICP-248 and Orelabrutinib for treating chronic lymphocytic leukemia

A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase2; Phase3 Interventional Beijing InnoCare Pharma Tech Co., Ltd. · NCT06378138

This study is testing if combining two medications, ICP-248 and Orelabrutinib, can help people with newly diagnosed chronic lymphocytic leukemia or small lymphocytic lymphoma feel better and improve their treatment results.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment226 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBeijing InnoCare Pharma Tech Co., Ltd. Industry-sponsored
Drugs / interventionsOrelabrutinib
Locations53 sites (Bengbu, Anhui and 52 other locations)
Trial IDNCT06378138 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of ICP-248 in combination with Orelabrutinib in patients diagnosed with treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study aims to determine how well these two medications work together to improve patient outcomes. Participants will be monitored for their response to the treatment and any side effects experienced during the trial. The study is designed for patients aged 18 to 80 who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who have been diagnosed with treatment-naïve CLL or SLL and meet the specified health criteria.

Not a fit: Patients who have previously received treatment for CLL or SLL may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new effective treatment option for patients with chronic lymphocytic leukemia.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in treating hematologic malignancies have shown promise in other studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
3. Having an indication for treatment that meets the criteria for iwCLL 2018
4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).

Exclusion Criteria:

1. Central nervous system involvement.
2. Concomitant Richter transformation.
3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
5. History of allogeneic stem cell transplantation.
6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
7. Presence of active infection that requires intravenous anti-infective therapy.
8. Hepatitis B or C virus infection.
9. History of immunodeficiency disease or Significant cardiovascular disease
10. Central nervous system disorders or Severe bleeding disorder
11. Alcohol or drug dependence.
12. Mental disorders or poor compliance.

Where this trial is running

Bengbu, Anhui and 52 other locations

+3 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 Hematologic Malignancies
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.