Diffuse Large B-Cell LymphomaPhase 2NCT05823701
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
A Phase 2 study testing Chidamide, Azacitidine and obinutuzumab in people with Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R 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
- What is being tested?
- Chidamide, Azacitidine and obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm).
- Histopathologically confirmed DLBCL.
- Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment.
- Life expectancy > 3 months.
- Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: serum creatinine clearance ≥30 mL/min; Lung function: SPO2>91% without oxygen;
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- Adequate bone marrow reserve: Hemoglobin ≥8 g/dL; Platelet count ≥75×10^9/L; Absolute neutrophil value ≥1.0×10^9/L; Platelet count ≥50×10^9/L, absolute neutrophil value ≥0.75×10^9/L if there is bone marrow invasion.
- The patient has the ability to understand and is willing to provide written informed consent.
- Agreement to practice birth control from the time of enrollment until the follow-up period of the study.
Who cannot join
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2);
- Uncontrolled active infection;
- Concurrent presence of other tumors requiring treatment or intervention;
- Current or expected need for systemic corticosteroid therapy;
- Pregnant or lactating women.
- Other psychological conditions that prevent patients from participating in the research or signing the informed consent.
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or does not meet the requirements for participation in the study.
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
About this study
Official title: A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.
Read the detailed description
The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Chidamide, Azacitidine, obinutuzumab, Liposomal mitoxantrone
- 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.
ChidamideDrug
Also called Tucidinostat
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
AzacitidineDrug
Also called AZA
100mg d1- d5 subcutaneous injection per cycle
obinutuzumabBiological
Also called Gazyva
1000mg d4 intravenous infusion per cycle
Liposomal mitoxantroneDrug
Also called PLM60
20mg/m2 d5 intravenous infusion per cycle
| Study group | Role | What they receive |
|---|---|---|
| Chidamide, Azacitidine Combined With GM(CAGM) Regimen | Experimental | R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study. Receives: Drug: Chidamide; Drug: Azacitidine; Biological: obinutuzumab; Drug: Liposomal mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Measured: At the end of Cycle 2 (each cycle is 28 days)
Complete response rate(CRR)
The rate of patients who achieved CR after treatment by CAGM regimen
Measured: At the end of Cycle 2 (each cycle is 28 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 30 days after last dose
Progression-free survival(PFS)
PFS will be assessed from the first CAGM given to date of progression, relapse, death or end of follow-up.
Measured: Up to 24 months after the end of last patients' treatment.
Overal survival(OS)
OS will be assessed from the first CAGM given to date of death or end of follow-up.
Measured: Up to 24 months after the end of last patients' treatment.
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Measured: At the end of Cycle 6 (each cycle is 28 days)
Complete response rate(CRR)
The rate of patients who achieved CR after treatment by CAGM regimen
Measured: At the end of Cycle 6 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start30 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823701
- Sponsor's protocol ID
- Jinzm003
- Status last verified
- Aug 2022
- First submitted
- 27 Feb 2023
- Last updated
- 21 Apr 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
- ClinicalTrials.gov ID
- NCT05823701
- Acronym / sponsor ID
- Jinzm003
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 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.
To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.
Detailed description
The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide, Azacitidine Combined With GM(CAGM) Regimen | Experimental | Drug: Chidamide, Drug: Azacitidine, Biological: obinutuzumab, Drug: Liposomal mitoxantroneR/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm).
- Histopathologically confirmed DLBCL.
- Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment.
- Life expectancy > 3 months.
Key exclusion criteria (8 listed)
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2);
- Uncontrolled active infection;
- Concurrent presence of other tumors requiring treatment or intervention;
- Current or expected need for systemic corticosteroid therapy;
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 |
|---|---|---|
| ChidamideAlso: Tucidinostat20 mg (4 capsules), d1, d4, d8, d11 orally per cycle | Drug | Chidamide, Azacitidine Combined With GM(CAGM) Regimen |
| AzacitidineAlso: AZA100mg d1- d5 subcutaneous injection per cycle | Drug | Chidamide, Azacitidine Combined With GM(CAGM) Regimen |
| obinutuzumabAlso: Gazyva1000mg d4 intravenous infusion per cycle | Biological | Chidamide, Azacitidine Combined With GM(CAGM) Regimen |
| Liposomal mitoxantroneAlso: PLM6020mg/m2 d5 intravenous infusion per cycle | Drug | Chidamide, Azacitidine Combined With GM(CAGM) Regimen |
Primary outcome
Overall response rate(ORR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Complete response rate(CRR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
The rate of patients who achieved CR after treatment by CAGM 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 30 days after last dose
Progression-free survival(PFS)
Time frame: Up to 24 months after the end of last patients' treatment.
Overal survival(OS)
Time frame: Up to 24 months after the end of last patients' treatment.
Overall response rate(ORR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Complete response rate(CRR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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 Phase 2 study testing Chidamide, Azacitidine and obinutuzumab 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 9 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 21 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.
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?
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) (time frame: At the end of Cycle 2 (each cycle is 28 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 21 Apr 2023.