Clincosm LogoSign in Get a demo

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

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04849351
Collaborator
(none)
185
Enrollment
36
Locations
1
Arm
43.6
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 14, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Relapsed/Refractory MZL and FL

Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Drug: HMPL-689
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Other Names:
  • Phosphatidylinositol 3-kinase-δ inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) [Baseline up to the last patient has completed 12 months after treatment.]

      Defined as the proportion of patients with CR or PR

    Secondary Outcome Measures

    1. Complete response (CR) rate [Baseline up to the last patient has completed 12 months after treatment.]

      Defined as the proportion of patients with CR.

    2. Progression-free survival (PFS) [Baseline up to the last patient has completed 12 months after treatment.]

      Defined as the time from the first dose of HMPL-689 to occurrence of PD or death, whichever comes first.

    3. Time to response (TTR) [Baseline up to the last patient has completed 12 months after treatment.]

      Defined as the time from the first dose of HMPL-689 to the first objective response.

    4. Duration of response (DoR) [Baseline up to the last patient has completed 12 months after treatment.]

      Defined as the time from the initial objective response to disease recurrence, progression or death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Anhui Medical University Hefei Anhui China 230601
    2 Beijing Chao-yang Hospital ，Capital Medical University Beijing Beijing China 100020
    3 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
    4 Beijing Cancer Hospital Beijing Beijing China 100142
    5 Peking University Third Hospital Beijing Beijing China 100191
    6 Chongqing University Cancer Hospital Chongqing Chongqing China 400030
    7 Fujian Cancer Hospital Fuzhou Fujian China 350014
    8 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361001
    9 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060
    10 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515
    11 Cancer Hospital of Shantou University Medical College Shantou Guangdong China 515031
    12 Guangxi Medical University Affiliated Tumor Hospital Nanning Guangxi China 530021
    13 Hainan General Hospital Haikou Hainan China 570311
    14 Puyang Oilfield General Hospital Puyang Henan China 410900
    15 Henan Cancer Hospital Zhengzhou Henan China 450003
    16 Henan Provincial People's Hospital Zhengzhou Henan China 450003
    17 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
    18 Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430000
    19 People's Hospital of Wuhan University Wuhan Hubei China 430061
    20 HuNan Cancer Hospital Changsha Hunan China 410013
    21 The Central Hospital of YongZhou Yongzhou Hunan China 425006
    22 The First People's Hospital of Nantong Nantong Jiangsu China 226001
    23 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    24 The First Hospital of Jilin University Changchun Jilin China 130000
    25 The affiliated hospital of Qingdao University Qingdao Shandong China 266000
    26 Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200092
    27 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200433
    28 Shanxi Bethune Hospital Taiyuan Shanxi China 30002
    29 West China Hospital Sichuan University Chengdu Sichuan China 610041
    30 Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan China 637000
    31 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060
    32 Cancer Hospital Affiliated to Xinjiang Medical University Ürümqi Xinjiang China 830000
    33 First Affiliated Hospital of Kunming Medical University Kunming Yunnan China
    34 The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China 310003
    35 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    36 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Principal Investigator: junning Cao, Ph.D, Fudan University
    • Principal Investigator: Zhiming Li, post-doc, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT04849351
    Other Study ID Numbers:
    • 2020-689-00CH3
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Jun 9, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hutchison Medipharma Limited
    Marginal Zone Lymphoma
    Follicular Lymphoma
    Phosphatidylinositol 3-kinase inhibitor
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Lymphoma, B-Cell, Marginal Zone

    Study Results

    No Results Posted as of Jun 9, 2021