SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-10-31

Brief Summary

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The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.

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Detailed Description

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Conditions

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Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR1459 + YY-20394 (Stage 1)

Group Type EXPERIMENTAL

SHR1459 ；YY-20394

1. Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
2. Patients received at least 2 lines of systemic therapy
3. Previously received anti- CD20 treatment
4. Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
5. Patients must have an acceptable organ function

Exclusion Criteria

1. Previously treated with PI3K inhibitors or BTK inhibitors
2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy
3. Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
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