Clinical trial · Interventional
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
NCT05823701CI-TRIAL-00065863unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| Liposomal mitoxantrone | Drug | — | UNRESOLVED |
| obinutuzumab | Biological | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide, Azacitidine Combined With GM(CAGM) Regimen
- description
- 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or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.
- interventionNames
- Drug: Chidamide
- Drug: Azacitidine
- Biological: obinutuzumab
- Drug: Liposomal mitoxantrone
Primary outcomes (2)
- measure
- Overall response rate(ORR)
- timeFrame
- At the end of Cycle 2 (each cycle is 28 days)
- description
- The rate of patients who achieved CR or PR after treatment by CAGM regimen
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. At least one measurable lesion,measurable lymph nodes or masses of at least 15 millimeter (mm). 3. Histopathologically confirmed DLBCL. 4. Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment. 5. Life expectancy \> 3 months. 6. 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; 7. 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. 8. The patient has the ability to understand and is willing to provide written informed consent. 9. Agreement to practice birth control from the time of enrollment until the follow-up period of the study. Exclusion Criteria: 1. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2); 3. Uncontrolled active infection; 4. Concurrent presence of other tumors requiring treatment or intervention; 5. Current or expected need for systemic corticosteroid therapy; 6. Pregnant or lactating women. 7. Other psychological conditions that prevent patients from participating in the research or signing the informed consent. 8. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.