Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05867030
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lenalidomide — DRUG
    lenalidomide is administered orally
  • rituximab — DRUG
    rituximab is administered intravenously
  • parsaclisib — DRUG
    parsaclisib is administered orally

Study Details

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

Key Dates

Start date
Jul 28, 2023
Status verified
Oct 2023
Primary completion
Aug 31, 2029
Completion
Apr 30, 2033

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR) [ Time Frame: within 6 months after last patient enrolled, an average of 2 years ]

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