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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378138
• Other study ID #: ICP-CL-01203
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 25, 2024
• Est. completion date: July 25, 2031

Study information

• Verified date: April 2024
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Alexia Lu
• Phone: 010-66609745
• Email: CO_HGRAC[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: July 25, 2031
• Est. primary completion date: November 25, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Suspected 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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• ICP-248
Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle
• Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol,once daily for every 28 days as one treatment cycle

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Bethune First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Xiangya Hospital, Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Linyi City Cancer Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanyang City Center Hospital	Nanyang	Henan
China	Huashan Hospital	Shanghai	Shanghai
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	The Affiliated Cancer Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhenzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria		Up to 6 years
Primary	Changes from baseline in pulse.		Up to 6 years
Primary	Changes from baseline in blood pressure.		Up to 6 years
Primary	Changes from baseline in ECG QRS interval.		Up to 6 years
Primary	Changes from baseline in ECG QT interval.		Up to 6 years