Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT06647940
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
A Phase 2 study testing Orelabrutinib Oral Tablet and R-CHOP Protocol in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Sun Yat-sen University at 11 sites in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Orelabrutinib Oral Tablet and R-CHOP Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 11 sitesChina
- Study dates
- 1 Nov 2024to 1 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18 years, both male and female.
- Pathologically confirmed CD5-positive DLBCL
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
- Expected survival ≥3 months.
- Sufficient bone marrow, liver, and kidney function.
Who cannot join
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- The patients had previously received BTK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
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- Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 510060
Yirong Jiang, 13688967985, 13688967985@org.cn
- Recruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou, China, 51000
Qing qing Cai, MD. PhD., 0086-20-87342823, caiqq@sysucc.org.cn
Yi Xia, MD. PhD., 0086-20-87342823, xiayi@sysucc.org.cn
- Recruiting
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510060
Runhui Zheng, 13560225061, 332520646@qq.com
- Recruiting
First People's Hospital of Guangzhou
Guangzhou, Guangdong
Tingfen Deng, 13642689191, 1255608195@qq.com
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Yuanbin Wu, 13711454979, wyb@gdhtcm.org.cn
- Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Xu Ye, 13060669127, yexu@gzhmu.edu.cn
- Recruiting
Gansu Cancer Hospital
Lanzhou, Gansu
Junfeng Jiang, 13893332604, jiangjunfeng@gsszlyy.cn
- Recruiting
First Affiliated Hospital of Shantou University Medical College.
Shantou, Guangdong
Yongzhong Su, 18038865106, fuyiyuanban@163.com
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Jihao Zhou, 18718678693, 2568341625@qq.com
- Recruiting
Zhaoqing First People's Hospital
Zhaoqing, Guangdong
Wei Lin, 13822658301, 1222567198@qq.com
- Recruiting
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 510060
Nan Chen, 13631270598, chennan9@mail.suysu.edu.cn
About this study
Official title: Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Read the detailed description
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
The primary endpoint is the 2-year event-free survival (EFS) rate.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Orelabrutinib Oral Tablet, R-CHOP Protocol
- Keywords
- DLBCL, Orelabrutinib, CD5-positive, R-CHOP
- 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.
Orelabrutinib Oral TabletDrug
Also called Bruton's Tyrosine Kinase Inhibitor
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
R-CHOP ProtocolDrug
Also called R-CHOP regimen
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib in combination with R-CHOP | Experimental | Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).
After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted. Receives: Drug: Orelabrutinib Oral Tablet; Drug: R-CHOP Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival (EFS) rate
To investigate the preliminary anti-tumor efficacy
Measured: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
Secondary outcomes (6)
Complete response rate (CRR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Measured: From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Objective response rate (ORR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (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 Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Gansu Cancer Hospital, First Affiliated Hospital of Shantou University Medical College, Southern Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Guangzhou First People's Hospital, Dongguan People's Hospital, First People's Hospital of Zhaoqing
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647940
- Sponsor's protocol ID
- B2024-570-01
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
- ClinicalTrials.gov ID
- NCT06647940
- Acronym / sponsor ID
- B2024-570-01
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- DLBCL, Orelabrutinib, CD5-positive, R-CHOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Gansu Cancer Hospital, First Affiliated Hospital of Shantou University Medical College, Southern Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Guangzhou First People's Hospital, Dongguan People's Hospital, First People's Hospital of Zhaoqing
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Oct 2024 (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 prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Detailed description
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
The primary endpoint is the 2-year event-free survival (EFS) rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib in combination with R-CHOP | Experimental | Drug: Orelabrutinib Oral Tablet, Drug: R-CHOP ProtocolPatients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18 years, both male and female.
- Pathologically confirmed CD5-positive DLBCL
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
Key exclusion criteria (9 listed)
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- The patients had previously received BTK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
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 Oral TabletAlso: Bruton's Tyrosine Kinase InhibitorOrelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen | Drug | Orelabrutinib in combination with R-CHOP |
| R-CHOP ProtocolAlso: R-CHOP regimenRituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone | Drug | Orelabrutinib in combination with R-CHOP |
Primary outcome
2-year event-free survival (EFS) rate
Time frame: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
To investigate the preliminary anti-tumor efficacy
6 secondary outcomes
Complete response rate (CRR)
Time frame: Up to 8 cycles (each cycle is 21 days)
Disease-free survival (DFS)
Time frame: From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Objective response rate (ORR)
Time frame: Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 2 years
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 22 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
11 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 Oral Tablet and R-CHOP Protocol in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Sun Yat-sen University at 11 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 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Qingqing Cai, MD. PhD. (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival (EFS) rate (time frame: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment). 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 22 Oct 2024.