Combination treatment for elderly patients with a specific type of lymphoma
A Prospective, Single-arm, Multicenter Clinical Study of Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Patients with Frail Treatment-naive Non-germinal Center Subtype Diffuse Large B-cell Lymphoma
This study is testing a new combination of medications to see if it can help frail elderly patients with a specific type of lymphoma feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | Polatuzumab, Rituximab, orelabrutinib |
| Locations | 2 sites (Nantong, Jiangsu and 1 other locations) |
| Trial ID | NCT06530511 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and efficacy of a combination regimen involving Polatuzumab, Rituximab, and Orelabrutinib in treating frail elderly patients with treatment-naive Non-GCB Diffuse Large B Cell Lymphoma (DLBCL). The study will enroll 30 participants and assess the complete response rate after induction therapy as the primary endpoint. It is a prospective, single-arm, multicenter trial designed to address the unique needs of this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60 and above with treatment-naive Non-GCB DLBCL who are considered frail or unfit based on specific evaluations.
Not a fit: Patients with uncontrolled cardiovascular or cerebrovascular diseases, severe autoimmune conditions, or significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for elderly frail patients suffering from Non-GCB DLBCL.
How similar studies have performed: While there have been studies on DLBCL treatments, this specific combination regimen in frail elderly patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients with histopathologically confirmed DLBCL;
* The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;
* Non-germinal center (Non-GCB) type;
* ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder \> 1.5 cm, or at least one extranodal lesion \> 1.0 cm in the longest diameter; ⑦ Adequate organ function;
* Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.
Exclusion Criteria:
* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;
* Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC \< 1.5 x 109/L, PLT \< 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance \< 60 mL/min (estimated by C OC kcroft-Gault formula); ③ HIV Infection;
* HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;
* Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A inhibitors or CYP3A Induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as Syndrome malabsorption, gastric or Small intestinal resection, symptomatic Inflammatory bowel disease or partial or complete Intestinal obstruction; ⑦ Other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with Psychosis or other patients known or suspected to be unable to fully comply with the study protocol.
Where this trial is running
Nantong, Jiangsu and 1 other locations
- Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
- Jiangsu Province Hospital — Nanjing, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Wenyu Shi
- Email: shiwenyu@hotmail.com
- Phone: +86 13515203737
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.