Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

NCT ID: NCT05867030

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-28

Study Completion Date

2033-04-30

Brief Summary

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

Detailed Description

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Conditions

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Follicular Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Parsaclisib+rituximab

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

Group Type EXPERIMENTAL

rituximab

Intervention Type DRUG

rituximab is administered intravenously

parsaclisib

Intervention Type DRUG

parsaclisib is administered orally

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).

Group Type EXPERIMENTAL

lenalidomide

Intervention Type DRUG

lenalidomide is administered orally

rituximab

Intervention Type DRUG

rituximab is administered intravenously

parsaclisib

Intervention Type DRUG

parsaclisib is administered orally

Interventions

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lenalidomide

lenalidomide is administered orally

Intervention Type DRUG

rituximab

rituximab is administered intravenously

Intervention Type DRUG

parsaclisib

parsaclisib is administered orally

Intervention Type DRUG

Other Intervention Names

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Lainamei Halpryza IBI376

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CIBI376A301

Identifier Type: -

Identifier Source: org_study_id

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