Diffuse Large B-Cell LymphomaPhase 2NCT05498259
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
A Phase 2 study testing Orelabrutinib, Rituximab and CHOP-like Regimen in people with Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Orelabrutinib, Rituximab and CHOP-like Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 1 Jan 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Non-GCB DLBCL
- Age ≥18 and ≤70 years
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)
- ECOG performance status 0-2
- Lymphoma International Prognostic Score (IPI) ≥ 2
- Life expectancy ≥ 6 months
- Adequate organ and marrow function
- Agreement to practice birth control from the time of enrollment until the follow-up period of the study
Who cannot join
- Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis
- All patients with primary central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist
- Requires treatment with strong /moderate CYP3A inhibitors or inducers
- Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease
- HIV infection and/or active hepatitis B or active hepatitis C infection
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- Uncontrolled active systemic infection
- Known hypersensitivity or contraindications to any drug involved in the study
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin
About this study
Official title: A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
Read the detailed description
The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Orelabrutinib, Rituximab, CHOP-like Regimen
- Keywords
- Orelabrutinib
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Orelabrutinib 150mg qd PO
RituximabBiological
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
CHOP-like RegimenDrug
cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib+R-CHOP-like | Experimental | Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with <25% tumor reduction, withdraw from the study，treat with R-CHOP-like alone for 6 cycle Receives: Drug: Orelabrutinib; Biological: Rituximab; Drug: CHOP-like Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The rate of patients who achieved complete response after treatment by OR-CHOP-like
Measured: At the end of Cycle 6（each cycle is 21 days）
Secondary outcomes (4)
Overall Response Rate (ORR)
The rate of patients who achieved CR or PR after treatment by OR-CHOP-like
Measured: At the end of Cycle 3 and Cycle 6（each cycle is 21 days）
Progression-free survival（PFS）
PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up
Measured: up to 24 month after the end of last patient's treatment
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Measured: initiation of study drug until 30 days after last dose
Mini response rate
The rate of patients who achieve ≥25% tumor reduction after OR treatment
Measured: the first 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start27 Jul 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498259
- Sponsor's protocol ID
- ORIENT
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data would be available at the First Affiliated Hospital and other researchers after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
- ClinicalTrials.gov ID
- NCT05498259
- Acronym / sponsor ID
- ORIENT
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Orelabrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Aug 2022 (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 purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
Detailed description
The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib+R-CHOP-like | Experimental | Drug: Orelabrutinib, Biological: Rituximab, Drug: CHOP-like RegimenOrelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with <25% tumor reduction, withdraw from the study，treat with R-CHOP-like alone for 6 cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed Non-GCB DLBCL
- Age ≥18 and ≤70 years
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)
- ECOG performance status 0-2
- Lymphoma International Prognostic Score (IPI) ≥ 2
Key exclusion criteria (9 listed)
- Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis
- All patients with primary central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist
- Requires treatment with strong /moderate CYP3A inhibitors or inducers
- Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease
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 |
|---|---|---|
| OrelabrutinibOrelabrutinib 150mg qd PO | Drug | Orelabrutinib+R-CHOP-like |
| RituximabRituximab 375 mg/m2 IV on Day 1 of each 21-day cycle | Biological | Orelabrutinib+R-CHOP-like |
| CHOP-like Regimencyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）. | Drug | Orelabrutinib+R-CHOP-like |
Primary outcome
Complete Response Rate
Time frame: At the end of Cycle 6（each cycle is 21 days）
The rate of patients who achieved complete response after treatment by OR-CHOP-like
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: At the end of Cycle 3 and Cycle 6（each cycle is 21 days）
Progression-free survival（PFS）
Time frame: up to 24 month after the end of last patient's treatment
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Time frame: initiation of study drug until 30 days after last dose
Mini response rate
Time frame: the first 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Yes. All the data would be available at the First Affiliated Hospital and other researchers after the end of the study
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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 Orelabrutinib, Rituximab and CHOP-like Regimen in people with Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University 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 8 inclusion and 9 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 3 Feb 2023. 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 Zhengming Jin (+86 0512 67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: At the end of Cycle 6（each cycle is 21 days）). 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 3 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.