Lymphoma, Large B-Cell, DiffusePhase 2NCT04022005
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
A Phase 2 study testing Chidamide, Rituximab, Gemcitabine,Oxaliplatin in people with Lymphoma, Large B-Cell, Diffuse, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Chidamide, Rituximab, Gemcitabine,Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2019to 11 Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy proved CD20+ DLBCL;
- relapse or refractory DLBCL#
- previously received systemic chemotherapy with anthracycline#
- not eligible for autologous hematopoietic stem cell transplantation#
- at least one evaluable lesion#
- ECOG PS 0-1;
- 18-75 years; without other malignancy;
- proper functioning of the major organs.
Who cannot join
- double-hit lymphoma;
- previously received treatment of HDAC inhibitor;
- plan to receive autologous stem cell transplantation;
- involvement of central nervous system;
- previously received gemcitabine within the past 6 months;
- patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 51000
About this study
Official title: Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Chidamide, Rituximab, Gemcitabine,Oxaliplatin
- 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.
Chidamide, Rituximab, Gemcitabine,OxaliplatinDrug
All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.
Patients with CR or PR will receive chidamide maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide combined with R-GemOx | Experimental | Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy. Receives: Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
Measured: 4-years
Secondary outcomes (3)
DOR
the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
Measured: 4-years
PFS
the time from the date of enrollment until either PD or death.
Measured: 4-years
OS
the time from the date of enrollment until death
Measured: 4-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start19 Jun 2019
- Primary completion16 Nov 2022
- Study completion11 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022005
- Sponsor's protocol ID
- B2019-091
- Status last verified
- Sep 2023
- First submitted
- 13 Jul 2019
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zou Q, Zhang Y, Zhou H, Lai Y, Cao Y, Li Z, Su N, Li W, Huang H, Liu P, Ye X, Wu Y, Tan H, Zheng R, Wu B, Yang H, Zhong L, Lu Y, Liang Y, Sun P, Li L, Liu Y, Dai D, Xia Y, Cai Q. Chidamide, a Histone Deacetylase Inhibitor, Combined With R-GemOx in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (TRUST): A Multicenter, Single-Arm, Phase 2 Trial. Cancer Med. 2025 May;14(9):e70919. doi: 10.1002/cam4.70919.
PubMed 40318003
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT04022005
- Acronym / sponsor ID
- B2019-091
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 11 Mar 2023 (actual)
- First posted
- 16 Jul 2019 (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 multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide combined with R-GemOx | Experimental | Drug: Chidamide, Rituximab, Gemcitabine,OxaliplatinChidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- biopsy proved CD20+ DLBCL;
- relapse or refractory DLBCL#
- previously received systemic chemotherapy with anthracycline#
- not eligible for autologous hematopoietic stem cell transplantation#
- at least one evaluable lesion#
Key exclusion criteria (6 listed)
- double-hit lymphoma;
- previously received treatment of HDAC inhibitor;
- plan to receive autologous stem cell transplantation;
- involvement of central nervous system;
- previously received gemcitabine within the past 6 months;
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 |
|---|---|---|
| Chidamide, Rituximab, Gemcitabine,OxaliplatinAll patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy. Patients with CR or PR will receive chidamide maintenance therapy. | Drug | Chidamide combined with R-GemOx |
Primary outcome
ORR
Time frame: 4-years
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
3 secondary outcomes
DOR
Time frame: 4-years
PFS
Time frame: 4-years
OS
Time frame: 4-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 40318003Zou Q, Zhang Y, Zhou H, Lai Y, Cao Y, Li Z, Su N, Li W, Huang H, Liu P, Ye X, Wu Y, Tan H, Zheng R, Wu B, Yang H, Zhong L, Lu Y, Liang Y, Sun P, Li L, Liu Y, Dai D, Xia Y, Cai Q. Chidamide, a Histone Deacetylase Inhibitor, Combined With R-GemOx in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (TRUST): A Multicenter, Single-Arm, Phase 2 Trial. Cancer Med. 2025 May;14(9):e70919. doi: 10.1002/cam4.70919.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chidamide, Rituximab, Gemcitabine,Oxaliplatin in people with Lymphoma, Large B-Cell, Diffuse, run by Sun Yat-sen 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 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: finished, as of the sponsor's last update on 11 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 4-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022005, which also lists 1 linked publication.
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 11 Sep 2023.