Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

• Status: Not yet recruiting
• Trial end date: 2033-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Lenalidomide; Rituximab

Criteria

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.