Follicular Lymphoma, Marginal Zone Lymphoma
Conditions
Keywords
Marginal Zone Lymphoma, Follicular Lymphoma, Phosphatidylinositol 3-kinase inhibitor
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)
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.
Interventions
DRUGHMPL-689
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Sponsors
Hutchison Medipharma Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rate | Baseline up to the last patient has completed 12 months after treatment. | Defined as the proportion of patients with CR. |
| 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. |
| 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. |
| 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. |
| Overall survival (OS) | Baseline up to the last patient has completed 12 months after treatment. | Defined as the time from the first dose with HMPL-689 to death from any cause. |
Countries
China
Outcome results
None listed