Clinical trial · Interventional
Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
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
NCT04849351CI-TRIAL-00088216completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-689 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relapsed/Refractory MZL and FL
- description
- Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
- interventionNames
- Drug: HMPL-689
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- Baseline up to the last patient has completed 12 months after treatment.
- description
- Defined as the proportion of patients with CR or PR
Secondary outcomes (5)
- measure
- Complete response (CR) rate
- timeFrame
- Baseline up to the last patient has completed 12 months after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.