Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT04849351|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : June 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma Follicular Lymphoma||Drug: HMPL-689||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 14, 2021|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Relapsed/Refractory MZL and FL
Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Other Name: Phosphatidylinositol 3-kinase-δ inhibitor
- Overall response rate (ORR) [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]Defined as the proportion of patients with CR or PR
- Complete response (CR) rate [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]Defined as the proportion of patients with CR.
- Progression-free survival (PFS) [ Time Frame: 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.
- Time to response (TTR) [ Time Frame: 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.
- Duration of response (DoR) [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥18 years;
- Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;
- 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);
- Expected survival of more than 12 weeks;
- Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion
- Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);
- Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
- Inadequate organ function of liver and kidney
- Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product
- Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product
- Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment
- Pregnant (positive serum pregnancy test) or lactating women
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04849351
|Contact: Xianlin Duanemail@example.com|
|Contact: Meiping Kong||86 21 2067 firstname.lastname@example.org|
|Principal Investigator:||junning Cao, Ph.D||Fudan University|
|Principal Investigator:||Zhiming Li, post-doc||Sun Yat-sen University|
|Responsible Party:||Hutchison Medipharma Limited|
|Other Study ID Numbers:||
|First Posted:||April 19, 2021 Key Record Dates|
|Last Update Posted:||June 9, 2021|
|Last Verified:||March 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Marginal Zone Lymphoma
Phosphatidylinositol 3-kinase inhibitor
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Immune System Diseases