Recurrent and Refractory B-cell Non-Hodgkin's LymphomaPhase 2NCT04948788
SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 2 study testing SHR1459 ；YY-20394 and Gemcitabine-Oxaliplatin in people with Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- SHR1459 ；YY-20394 and Gemcitabine-Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, 200025
Weili Zhao
About this study
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
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.
- Being tested
- SHR1459 ；YY-20394, Gemcitabine-Oxaliplatin
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1459 ；YY-20394Drug
SHR1459 plus YY-20394
SHR1459 ；YY-20394Drug
SHR1459 plus YY-20394
Gemcitabine-OxaliplatinDrug
Gemcitabine-Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| SHR1459 + YY-20394 (Stage 1) | Experimental | Not described Receives: Drug: SHR1459 ；YY-20394 |
| SHR1459 + YY-20394 (Stage 2) | Experimental | Not described Receives: Drug: SHR1459 ；YY-20394 |
| GemOx (Stage 2) | Experimental | Not described Receives: Drug: Gemcitabine-Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
Measured: Minimum observation period is 28 days for the maximum dose cohort
Stage 2: Overall response rate (ORR)
Measured: 8 weeks after last patient first visit (LPFV)
Secondary outcomes (1)
Incidence of Adverse Events
Measured: At every treatment and follow up visit until disease progression. Expected to be for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent and Refractory B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948788
- Sponsor's protocol ID
- SHR1459-II-201
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04948788
- Acronym / sponsor ID
- SHR1459-II-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| SHR1459 + YY-20394 (Stage 1) | Experimental | Drug: SHR1459 ；YY-20394 |
| SHR1459 + YY-20394 (Stage 2) | Experimental | Drug: SHR1459 ；YY-20394 |
| GemOx (Stage 2) | Experimental | Drug: Gemcitabine-Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR1459 ；YY-20394SHR1459 plus YY-20394 | Drug | SHR1459 + YY-20394 (Stage 1) |
| SHR1459 ；YY-20394SHR1459 plus YY-20394 | Drug | SHR1459 + YY-20394 (Stage 2) |
| Gemcitabine-OxaliplatinGemcitabine-Oxaliplatin | Drug | GemOx (Stage 2) |
Primary outcome
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
Stage 2: Overall response rate (ORR)
Time frame: 8 weeks after last patient first visit (LPFV)
1 secondary outcome
Incidence of Adverse Events
Time frame: At every treatment and follow up visit until disease progression. Expected to be for up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR1459 ；YY-20394 and Gemcitabine-Oxaliplatin in people with Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Wang (021-61053363, weiwei.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.