Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
Phase 1
Withdrawn
- Conditions
- Follicular Lymphoma
- Interventions
- Registration Number
- NCT05867030
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age ≥18 years old.
- Histopathological diagnosis as FL Grade1, 2 or 3a
- The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
- Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements > 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm.
- Life expectancy ≥12 weeks.
Exclusion criteria:
- Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
- A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
- Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
- Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
- pregnant or lactating women.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parsaclisib+rituximab rituximab parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1). Parsaclisib+rituximab + lenalidomide lenalidomide parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles). Parsaclisib+rituximab + lenalidomide rituximab parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles). Parsaclisib+rituximab parsaclisib parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1). Parsaclisib+rituximab + lenalidomide parsaclisib parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles).
- Primary Outcome Measures
Name Time Method Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR) within 6 months after last patient enrolled, an average of 2 years The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction within 6 months after last patient enrolled, an average of 2 years The duration from randomization to disease progression as assessed by an Independent Evaluation Committee (IRC) according to the revised Lymphoma Response Evaluation Criteria (Lugano 2014 criteria) or all-cause death. up to all subjects reached PFS endpoint, an average of 5 year
- Secondary Outcome Measures
Name Time Method Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria. Up to all subjects complete the study treatment, an average of 5 years The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction within 12 months after last patient enrolled, an average of 2.5 years