Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 1

Withdrawn

• Conditions: Follicular Lymphoma
• Interventions: Drug: rituximab; Drug: lenalidomide; Drug: parsaclisib

• 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

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Study Start: 2023-07-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-15
• Last Update Posted: 2023-10-17
• Primary Completion: 2029-08-31
• Study Completion: 2033-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥18 years old.
2. Histopathological diagnosis as FL Grade1, 2 or 3a
3. The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
4. 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.
5. Life expectancy ≥12 weeks.

Exclusion criteria:

1. Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
2. A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
3. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
4. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
5. 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