Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Innovent Biologics

Status and phase: Withdrawn; Phase 1

Conditions: Follicular Lymphoma

Treatments: Drug: parsaclisib; Drug: lenalidomide; Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05867030

CIBI376A301

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Parsaclisib+rituximab

Experimental group

Description:

parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1).

Treatment:

Drug: rituximab

Drug: parsaclisib

Parsaclisib+rituximab + lenalidomide

Experimental group

Description:

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).

Treatment:

Drug: rituximab

Drug: lenalidomide

Drug: parsaclisib