ICP-248 in Combination with Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2

Recruiting

• Conditions: Hematologic Malignancies
• Interventions: Drug: ICP-248; Drug: Orelabrutinib

• Registration Number: NCT06378138
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Study Start: 2024-05-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2030-11-25
• Study Completion: 2031-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-248 in combination with Orelabrutinib	ICP-248	-
ICP-248 in combination with Orelabrutinib	Orelabrutinib	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria	Up to 6 years
Changes from baseline in pulse.	Up to 6 years
Changes from baseline in blood pressure.	Up to 6 years
Changes from baseline in ECG QRS interval.	Up to 6 years
Changes from baseline in ECG QT interval.	Up to 6 years

Trial Locations

Locations (50)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China); 🇨🇳 Hefei, Anhui, China

Gansu Provincial People's Hospital; 🇨🇳 Lanzhou, Gansu, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

The Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

The Affiliated Hospital of North China University of Science and Technology; 🇨🇳 Tangshan, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Yichang Central People's Hospital; 🇨🇳 Yichang, Hubei, China

Changzhou First People's Hospital; 🇨🇳 Changzhou, Jiangsu, China

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