Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Study Overview
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Brief Summary
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A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma

Official Title
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A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: lenalidomide
* Drug: rituximab
* Drug: parsaclisib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parsaclisib+rituximab<br>parsaclisib（2.5 mg QD，D1 D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1). | Drug: rituximab<br>* rituximab is administered intravenously<br>* Other names: Halpryza;Drug: parsaclisib<br>* parsaclisib is administered orally<br>* Other names: IBI376;|
| Experimental: Parsaclisib+rituximab + lenalidomide<br>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). | Drug: lenalidomide<br>* lenalidomide is administered orally<br>* Other names: Lainamei;Drug: rituximab<br>* rituximab is administered intravenously<br>* Other names: Halpryza;Drug: parsaclisib<br>* parsaclisib is administered orally<br>* Other names: IBI376;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |