Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Follicular Lymphoma Clinical Trial

Official title:

A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients With Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849351
• Other study ID #: 2020-689-00CH3
• Status: Recruiting
• Phase: Phase 2
• Start date: April 14, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2021
• Source: Hutchison Medipharma Limited
• Contact: Xianlin Duan
• Phone: 021-20678852
• Email: xianlind[@]hmplglobal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL)

Description:

This is a multi-center, single-arm, open-label clinical study to evaluate the oral therapy with HMPL-689 in patients with relapsed / refractory MZL and FL. Relapse / refractory is defined as such a situation when a patient has not achieved response (CR or PR) after the latest line of systemic treatment, or has disease progress (PD) or relapse after achieving response. Two (2) cohorts of patients will be enrolled in this study:

Cohort 1: approximately 81 patients with histologically confirmed MZL

Cohort 2: approximately 104 patients with histologically confirmed FL (pathological grade 1-3a)

All patients are to receive monotherapy of HMPL-689 30 mg once a day (QD) continuously in 28-day treatment cycles until PD / recurrence, patient death, intolerable toxicity, initiation of other antitumor therapy, the patient unable to further benefit from the study treatment as judged by the investigators, the patient or his/her legal representative's request to withdraw from the clinical study treatment, the patient lost to follow-up or end of the study, whichever comes first.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma

3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;

4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (the longest diameter of nodal lesion > 1.5 cm or extranodal lesion > 1 cm);

5. Expected survival of more than 12 weeks;

Exclusion Criteria:

1. Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion

2. Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);

3. Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor or Bruton's tyrosine kinase (BTK) inhibitor

4. Inadequate organ function of liver and kidney

5. Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)

6. Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product

7. Toxicity of previous antitumor therapy not recovered to CTCAE grade = 1, except alopecia, prior to the first dose of the investigational product

8. Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment

9. Pregnant (positive serum pregnancy test) or lactating women

10. Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, one disease or state providing a reason to suspect that the subject is not suitable for HMPL-689 at the investigator's discretion, or one condition that will affect interpretation of the study results or bring the subject at high risk.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Marginal Zone Lymphoma

Intervention

Drug:
• HMPL-689
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chao-yang Hospital ,Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	HuNan Cancer Hospital	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	The First People's Hospital of Nantong	Nantong	Jiangsu
China	Puyang Oilfield General Hospital	Puyang	Henan
China	The affiliated hospital of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Cancer Hospital Affiliated to Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Central Hospital of YongZhou	Yongzhou	Hunan
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Defined as the proportion of patients with CR or PR	Baseline up to the last patient has completed 12 months after treatment.
Secondary	Complete response (CR) rate	Defined as the proportion of patients with CR.	Baseline up to the last patient has completed 12 months after treatment.
Secondary	Progression-free survival (PFS)	Defined as the time from the first dose of HMPL-689 to occurrence of PD or death, whichever comes first.	Baseline up to the last patient has completed 12 months after treatment.
Secondary	Time to response (TTR)	Defined as the time from the first dose of HMPL-689 to the first objective response.	Baseline up to the last patient has completed 12 months after treatment.
Secondary	Duration of response (DoR)	Defined as the time from the initial objective response to disease recurrence, progression or death.	Baseline up to the last patient has completed 12 months after treatment.