A Study of Linperlisib (YY-20394) in Combination With Rituximab in Patients With Relapsed/Refractory Indolent NHL

NCT ID: NCT06981988

Last Updated: 2025-05-21

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-02-28

Brief Summary

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The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.

Detailed Description

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Conditions

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Relapsed/Refractory Indolent NHL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Linperlisib + Rituximab

Group Type EXPERIMENTAL

Linperlisib ; Rituximab

Intervention Type DRUG

Linperlisib ; Rituximab

Interventions

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Linperlisib ; Rituximab

Linperlisib ; Rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients received at least 1 lines of systemic therapy
2. Previously received anti- CD20 treatment
3. Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi \> 1.5 cm or extranodal site Ldi \> 1.0cm)
4. Patients must have an acceptable organ function

Exclusion Criteria

1. Previously treated with PI3K inhibitors
2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy
3. Chemotherapy or other antitumor therapy within 14 days before starting cycle one
4. Significant concurrent medical disease or condition which according to the investigators' judgement
5. Active hepatitis B, C or HIV infection
6. Infection requiring treatment 2 weeks prior to the first dosing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhenyu Xiao

Role: CONTACT

021-61053363

Other Identifiers

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HRS3536-III-301

Identifier Type: -

Identifier Source: org_study_id

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