Clinical trial · Interventional
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)
NCT03768505CI-TRIAL-00084209terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): discontinuation of zandelisib program
Summary
Brief summary (as posted)
This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy
Conditions
Conditions (3)
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 (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zandelisib (ME-401) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zandelisib (ME-401) open label
- description
- Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
- interventionNames
- Drug: Zandelisib (ME-401)
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
- timeFrame
- 3 years 9 months
- description
- ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
Secondary outcomes (6)
- measure
- Duration of Response (DOR)
- timeFrame
- 3 years 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme 1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or 2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL * Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL * Age ≥ 18 * At least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification * Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment * QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec); * Left ventricular ejection fraction (LVEF) ≥ 45% Exclusion Criteria: * Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma * Known lymphomatous involvement of the central nervous system * Uncontrolled clinically significant illness * Ongoing or history of drug-induced pneumonitis * History of clinically significant cardiovascular abnormalities * History of clinically significant GI conditions * Known history of, or active HIV infection
References
Publications (0)
Data not yet available
No reference posted for this study.