Using zanubrutinib and lenalidomide for maintenance in lymphoma patients
Zanubrutinib and Lenalidomide as Maintenance Therapy in Patients With Diffuse Large B-cell Lymphoma
This study is testing whether the combination of zanubrutinib and lenalidomide can help people with diffuse large B-cell lymphoma stay in remission after chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Drugs / interventions | chemotherapy, zanubrutinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06503263 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial aims to evaluate the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy for patients with diffuse large B-cell lymphoma (DLBCL) who have achieved complete remission after chemotherapy. The study will assess event-free survival, progression-free survival, overall survival, and any adverse events associated with the treatment. Participants will receive these medications to help maintain their remission and prevent disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with DLBCL and have achieved complete remission after chemotherapy.
Not a fit: Patients with active infections or those who have not achieved complete remission after chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve long-term outcomes for patients with DLBCL by prolonging remission and reducing the risk of relapse.
How similar studies have performed: Other studies have shown promising results with similar maintenance therapies in lymphoma, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification; * Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). * Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted; * Patient is willing and able to adhere to the study visit schedule and other protocol requirements; * Patient has recieved complete remission and has completed planed courses of chemotherapy * Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months Exclusion Criteria: * Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * Pregnant or lactating women
Where this trial is running
Beijing, Beijing Municipality
- Navy General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: qlr2007@126.com Qian, PhD — Navy General Hospital, Beijing
- Study coordinator: Liren Qian, PhD
- Email: qlr2007@126.com
- Phone: +861066947192
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.