Back to resultsSHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Primary Purpose
Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR1459 ；YY-20394
SHR1459 ；YY-20394
Gemcitabine-Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
- Patients received at least 2 lines of systemic therapy
- Previously received anti- CD20 treatment
- Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
- Patients must have an acceptable organ function
Exclusion Criteria:
- Previously treated with PI3K inhibitors or BTK inhibitors
- Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
- Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
- Significant concurrent medical disease or condition which according to the investigators' judgement
- Active hepatitis B, C or HIV infection
- Infection requiring treatment 2 weeks prior to the first dosing
Sites / Locations
- Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SHR1459 + YY-20394 (Stage 1)
SHR1459 + YY-20394 (Stage 2)
GemOx (Stage 2)
Arm Description
Outcomes
Primary Outcome Measures
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
Stage 2: Overall response rate (ORR)
Secondary Outcome Measures
Incidence of Adverse Events
Full Information
NCT ID
NCT04948788
First Posted
June 28, 2021
Last Updated
September 22, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04948788
Brief Title
SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
Official Title
A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR1459 + YY-20394 (Stage 1)
Arm Type
Experimental
Arm Title
SHR1459 + YY-20394 (Stage 2)
Arm Type
Experimental
Arm Title
GemOx (Stage 2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR1459 ；YY-20394
Intervention Description
SHR1459 plus YY-20394
Intervention Type
Drug
Intervention Name(s)
SHR1459 ；YY-20394
Intervention Description
SHR1459 plus YY-20394
Intervention Type
Drug
Intervention Name(s)
Gemcitabine-Oxaliplatin
Intervention Description
Gemcitabine-Oxaliplatin
Primary Outcome Measure Information:
Title
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
Time Frame
Minimum observation period is 28 days for the maximum dose cohort
Title
Stage 2: Overall response rate (ORR)
Time Frame
8 weeks after last patient first visit (LPFV)
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
At every treatment and follow up visit until disease progression. Expected to be for up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
Patients received at least 2 lines of systemic therapy
Previously received anti- CD20 treatment
Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
Patients must have an acceptable organ function
Exclusion Criteria:
Previously treated with PI3K inhibitors or BTK inhibitors
Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
Significant concurrent medical disease or condition which according to the investigators' judgement
Active hepatitis B, C or HIV infection
Infection requiring treatment 2 weeks prior to the first dosing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiwei Wang
Phone
021-61053363
Email
weiwei.wang@hengrui.com
Facility Information:
Facility Name
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
12. IPD Sharing Statement
Learn more about this trial
SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
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