The First Affiliated Hospital of Nanchang UniversityPhase 2NCT05933967
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
A Phase 2 study testing Orelabrutinib+R-CHOP in people with The First Affiliated Hospital of Nanchang University, run by Shandong Cancer Hospital and Institute at 2 sites in China.
Trial summary
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- The First Affiliated Hospital of Nanchang University
- What is being tested?
- Orelabrutinib+R-CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
- Age 18-70 years
- ECOG performance status 0-2
- Ann Arbor stage II-IV
- 8.Subjects who in line with the testing standard of the clinical trial laboratory
- Life expectancy ≥ 3months
Who cannot join
- • systemic lymphoma involved CNS.
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
- uncontrolled infections (including HBV, HCV, HIV/AIDS)
- Subjects who prepared for transplantation
- Pregnancy or active lactation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dan Liu contact
China2 sites, 2 recruiting
- Recruiting
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong
zengjun Li
- Recruiting
The First Ailliated Hospital of Nanchang University
Nanchang, Jiangxi
Fei Li
About this study
Official title: A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
Read the detailed description
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
- Being tested
- Orelabrutinib+R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib+R-CHOPDrug
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.
| Study group | Role | What they receive |
|---|---|---|
| orelabrutinib+R-CHOP | Experimental | Not described Receives: Drug: Orelabrutinib+R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
Measured: up to 24 weeks
Secondary outcomes (4)
ORR
ORR is defined as the proportion of patients with a best response of CR or PR
Measured: up to 24 weeks
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Measured: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years overall survival
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
Measured: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The First Affiliated Hospital of Nanchang UniversityStudies of the same condition, open and under way.
- 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Zengjun Li, Shandong Cancer Hospital and Institute
- Investigators
- zengjun Li, Study chair, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933967
- Sponsor's protocol ID
- SDCHI-NHL-001
- Status last verified
- Aug 2023
- First submitted
- 16 Jun 2023
- Last updated
- 15 Aug 2023
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05933967
- Acronym / sponsor ID
- SDCHI-NHL-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Jul 2023 (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.
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
Detailed description
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
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 | Experimental | Drug: Orelabrutinib+R-CHOP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
Key exclusion criteria (5 listed)
- • systemic lymphoma involved CNS.
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 |
|---|---|---|
| Orelabrutinib+R-CHOPOrelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison. | Drug | orelabrutinib+R-CHOP |
Primary outcome
complete response rate
Time frame: up to 24 weeks
4 secondary outcomes
ORR
Time frame: up to 24 weeks
2 years progression-free survival
Time frame: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years overall survival
Time frame: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
The occurrence of adverse events and serious adverse events
Time frame: up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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.
Dan Liu contact
zengjun Li study chair
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
2 sites 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+R-CHOP in people with The First Affiliated Hospital of Nanchang University, run by Shandong Cancer Hospital and Institute at 2 sites 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zengjun Li (13642138692, zengjunli@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: up to 24 weeks). 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 15 Aug 2023.