Treatment for elderly patients with newly diagnosed double-expressor lymphoma
Rituximab，Lenalidomide and Chidamide Followed by CR-CHOP in Elderly Patients with Newly-diagnosed Double-expressor Lymphoma
This study is testing a new combination of treatments for older patients with a specific type of lymphoma to see if it helps them feel better and stay in remission.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06674096 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a sequential immunochemotherapy regimen combining chidamide, rituximab, and lenalidomide in elderly patients diagnosed with double-expressor diffuse large B-cell lymphoma (DLBCL). The study is structured into four phases: screening, induction therapy, immunochemotherapy, and maintenance therapy. Patients will receive the RLC regimen followed by the CR-miniCHOP regimen, with maintenance therapy for those who achieve complete remission. The trial aims to provide a comprehensive treatment approach for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 70 years old or those aged 65 and older with a specific performance status and confirmed double-expressor DLBCL.
Not a fit: Patients with certain pathological subtypes of lymphoma or those with central nervous system involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for elderly patients with double-expressor lymphoma.
How similar studies have performed: Other studies have shown promise in treating double-expressor lymphoma with similar immunochemotherapy approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Untreated DLBCL patients confirmed by histopathology 2. Immunohistochemistry showed positive expression of MYC and BCL2 protein (double expressor lymphoma, MYC≥40%, BCL2≥50%) 3. age over 70 years old or age ≥65 years old and ECOG score ≥2 points, both male and female 4. Having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter \> 1.5 cm, or at least one extranodal lesion with a maximum diameter \> 1.0 cm, and at least two vertical diameters that can be accurately measured. 5\. ECOG PS≤3 6. Expected survival time ≥3 months 7. voluntary participation in clinical research; Fully understand and understand the study and sign the informed consent; Willingness to follow and ability to complete all research steps. Exclusion Criteria: * 1\. The pathological subtypes were PCNSL, PMBCL, EBV-positive DLBCL and HGBL 2. Hemophagocytic syndrome accompanied the diagnosis 3. Central nervous system involvement is secondary to lymphoma 4. Are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. HIV infection 6. Major surgery was performed within 28 days prior to study start 7. Any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. The patients considered by the investigator to be unsuitable for participating in this study
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Chen Xi
- Email: zjuchenxi@126.com
- Phone: +8617816890591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.