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NCT05867030 | Withdrawn | Follicular Lymphoma

Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
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

Condition or disease

Follicular Lymphoma

Intervention/treatment

lenalidomide

rituximab

parsaclisib

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : Single
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : July 28, 2023
Estimated Primary Completion Date : August 31, 2029
Estimated Study Completion Date : April 30, 2033
Arm Intervention/treatment

Experimental: Parsaclisib+rituximab

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

Drug: rituximab

Drug: parsaclisib

Experimental: Parsaclisib+rituximab + 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).

Drug: lenalidomide

Drug: rituximab
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

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Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

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