Combination treatment for patients with relapsed and refractory DLBCL

A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL

This study is testing a new combination treatment for people with relapsed or hard-to-treat diffuse large B-cell lymphoma to see if it can help them respond better to therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: obinutuzumab, rituximab, orelabrutinib, CAR-T
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05823701 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a combination regimen known as CAGM, which includes chidamide, azacitidine, obinutuzumab, and liposomal mitoxantrone, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants will undergo an initial two cycles of induction therapy, followed by imaging to assess response rates. Depending on their response, patients may receive sequential CAR-T cell therapy or additional cycles of CAGM immunochemotherapy. The goal is to provide a more effective treatment option for this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed DLBCL that is refractory to first-line treatment or has relapsed after the last treatment.

Not a fit: Patients who are not eligible include those with a life expectancy of less than three months or those with significant organ dysfunction.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with relapsed and refractory DLBCL.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating DLBCL, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Suzhou, Jiangsu

• the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhengming Jin

Conditions Diffuse Large B-Cell Lymphoma