DLBCL - Diffuse Large B Cell LymphomaPhase 2DragonNCT06778902
AZA Combined with R-GemOx for Elderly DLBCL Patients
A Phase 2 study testing azacytidine and R-GemOx in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- azacytidine and R-GemOx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Jan 2028
- 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 60 to 90 years
- 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 ≥60 years, both male and female.
- Pathologically confirmed DLBCL
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- No previous chemotherapy or radiotherapy for DLBCL has been received.
- Expected survival ≥3 months.
Who cannot join
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- 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.
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Daping Hospital, Third Military Medical University (Army Medical University)
Chongqing, 400000
Dongfeng Zeng, PHD, 86+13396081757, zengdf@tmmu.edu.cn
About this study
Official title: AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly 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 AZA in combination with R-GemOx for untreated elderly DLBCL patients.
The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.
The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- azacytidine, R-GemOx
- Keywords
- Diffuse large B-cell lymphoma, GemOx, R, AZA
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacytidineDrug
Azacytidine: 75mg/m2, d1-d5
R-GemOxDrug
Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7
| Study group | Role | What they receive |
|---|---|---|
| AZA+GemOx | Experimental | Elderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy. Receives: Drug: azacytidine; Drug: R-GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Secondary outcomes (5)
Complete remission(CR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Partial remission(PR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
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
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
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 posted16 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778902
- Sponsor's protocol ID
- 2024-322
- Other IDs
- ZXYZZKY07
- Acronym
- Dragon
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06778902
- Acronym / sponsor ID
- Dragon / 2024-322
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, GemOx, R, AZA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Jan 2025 (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 AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly 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 AZA in combination with R-GemOx for untreated elderly DLBCL patients.
The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.
The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZA+GemOx | Experimental | Drug: azacytidine, Drug: R-GemOxElderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥60 years, both male and female.
- Pathologically confirmed DLBCL
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- No previous chemotherapy or radiotherapy for DLBCL has been received.
Key exclusion criteria (6 listed)
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- 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.
- Mentally ill persons or persons unable to obtain informed consent.
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 |
|---|---|---|
| azacytidineAzacytidine: 75mg/m2, d1-d5 | Drug | AZA+GemOx |
| R-GemOxRituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7 | Drug | AZA+GemOx |
Primary outcome
Objective response rate(ORR)
Time frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
5 secondary outcomes
Complete remission(CR)
Time frame: Up to 8 cycles (each cycle is 21 days)
Partial remission(PR)
Time frame: Up to 8 cycles (each cycle is 21 days)
Overall Survival (OS)
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
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
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 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 azacytidine and R-GemOx in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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 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: opening soon, as of the sponsor's last update on 16 Jan 2025. 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?
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 Dongfeng Zeng, Pro (86+18680887505, zengdf@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: Up to 8 cycles (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 16 Jan 2025.