Diffuse Large B Cell LymphomaNCT05809180
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
A study testing Rituximab, Orelabrutinib and Pomalidomide 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 proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Rituximab, Orelabrutinib and Pomalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 3 Jul 2026
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
- There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
- Age ≥ 70 years;
- Life expectancy >3 months;
- Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine < 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2>90% under non-oxygenated conditions).
- Written informed consent obtained from the subject.
Who cannot join
- Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
- Uncontrolled active infection;
- Patients with central nervous system DLBCL;
- A history of vascular embolism;
- Co-existence of other tumors;
- Systemic corticosteroid therapy is needed;
- Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
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, +86 0512 67781856, jinzhengming519519@163.com
Nana Ping, 67781856, ping.chengcheng@163.com
About this study
Official title: Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.
Read the detailed description
The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Rituximab, Orelabrutinib, Pomalidomide, Pro-miniCHOP-like regimen, R-miniCHOP-like regimen
- Keywords
- Diffuse Large B-Cell Lymphoma, Orelabrutinib, pomalidomide, Rituximab
- 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.
RituximabDrug
Also called MabThera
Rituximab 375mg/m2 ivgtt d1;
OrelabrutinibDrug
Also called Yinuokai
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
PomalidomideDrug
Also called Anyve
Pomalidomide 4mg d1-7 each cycle. After Phase II of treatment, single agent pomalidomide 4 mg d1-d7 in 21-day cycles for 2 years.
Pro-miniCHOP-like regimenDrug
rituximab 375mg/m2 ivgtt d1; orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; pomalidomide 4mg d1-7; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.
R-miniCHOP-like regimenDrug
rituximab 375mg/m2 ivgtt d1; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.
| Study group | Role | What they receive |
|---|---|---|
| rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like | Experimental | 1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day.
2. Phase II(stratified response therapy):
Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6).
Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6).
3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years. Receives: Drug: Rituximab; Drug: Orelabrutinib; Drug: Pomalidomide; Drug: Pro-miniCHOP-like regimen; Drug: R-miniCHOP-like regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen.
Measured: At the end of cycle 6 (each cycle is 21 days)
Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.
Measured: At the end of cycle 6 (each cycle is 21 days)
Secondary outcomes (5)
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 28 days after last dose
Overall Response Rate(ORR) after Pro induction regimen
The rate of patients who achieved complete response and partial response after Pro induction regimen.
Measured: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Complete Response Rate(CRR) after Pro induction regimen
The rate of patients who achieved complete response after Pro induction regimen.
Measured: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Overall Survival (OS)
OS will be assessed from the first drug given to date of death or end of follow-up.
Measured: Up to 2 years after the end of last patient's treatment
Progression Free Survival (PFS)
PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.
Measured: Up to 2 years after the end of last patient's treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start4 Jan 2023
- Primary completion3 Jul 2025 (estimated)
- Study completion3 Jul 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809180
- Sponsor's protocol ID
- Jinzm 005
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2023
- Last updated
- 20 Apr 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
- ClinicalTrials.gov ID
- NCT05809180
- Acronym / sponsor ID
- Jinzm 005
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse Large B-Cell Lymphoma, Orelabrutinib, pomalidomide, Rituximab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 12 Apr 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.
The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.
Detailed description
The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like | Experimental | Drug: Rituximab, Drug: Orelabrutinib, Drug: Pomalidomide, Drug: Pro-miniCHOP-like regimen, Drug: R-miniCHOP-like regimen1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. Phase II(stratified response therapy): Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
- There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
- Age ≥ 70 years;
- Life expectancy >3 months;
- Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine < 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2>90% under non-oxygenated conditions).
Key exclusion criteria (8 listed)
- Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
- Uncontrolled active infection;
- Patients with central nervous system DLBCL;
- A history of vascular embolism;
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 |
|---|---|---|
| RituximabAlso: MabTheraRituximab 375mg/m2 ivgtt d1; | Drug | rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like |
| OrelabrutinibAlso: YinuokaiOrelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; | Drug | rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like |
| PomalidomideAlso: AnyvePomalidomide 4mg d1-7 each cycle. After Phase II of treatment, single agent pomalidomide 4 mg d1-d7 in 21-day cycles for 2 years. | Drug | rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like |
| Pro-miniCHOP-like regimenrituximab 375mg/m2 ivgtt d1; orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; pomalidomide 4mg d1-7; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6. | Drug | rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like |
| R-miniCHOP-like regimenrituximab 375mg/m2 ivgtt d1; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6. | Drug | rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like |
Primary outcome
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
Time frame: At the end of cycle 6 (each cycle is 21 days)
The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen.
Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
Time frame: At the end of cycle 6 (each cycle is 21 days)
The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.
5 secondary outcomes
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
Time frame: Initiation of study drug until 28 days after last dose
Overall Response Rate(ORR) after Pro induction regimen
Time frame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Complete Response Rate(CRR) after Pro induction regimen
Time frame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Overall Survival (OS)
Time frame: Up to 2 years after the end of last patient's treatment
Progression Free Survival (PFS)
Time frame: Up to 2 years after the end of last patient's treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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 study testing Rituximab, Orelabrutinib and Pomalidomide 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 6 inclusion and 8 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 20 Apr 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.
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 (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen (time frame: At the end of cycle 6 (each cycle is 21 days)). 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 20 Apr 2023.