Treatment for newly diagnosed untreated mantle cell lymphoma
A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
This study is testing a new treatment without chemotherapy for adults with newly diagnosed mantle cell lymphoma to see if it helps them respond better than current options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | rituximab, zanubrutinib, immunotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05504603 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the safety and efficacy of a new chemo-free treatment regimen combining zanubrutinib and rituximab in patients over 18 years old with untreated mantle cell lymphoma. The study involves an initial 28-day induction phase followed by four cycles of consolidation therapy, with patients evaluated for response rates through imaging. Those achieving stable disease or progressive disease will be withdrawn, while responders will be stratified for further treatment based on their age and physical status. Eligible patients may receive oral zanubrutinib maintenance or undergo autologous stem cell transplantation based on their fitness for the procedure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed untreated mantle cell lymphoma.
Not a fit: Patients with indolent mantle cell lymphoma or severe liver and kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, effective option for patients with newly diagnosed mantle cell lymphoma without the need for chemotherapy.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases; 2. Initial untreated patients; 3. Age ≥ 18 years; 4. ECOG score 0-2; 5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. Male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter; 6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination); 7. Written informed consent obtained from the subject. Exclusion Criteria: 1. Indolent Mantle Cell Lymphoma; 2. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal) 3. Uncontrolled active infection, with the exception of tumor-related B symptom fever; 4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2); 5. Co-existence of other tumors; 6. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Where this trial is running
Suzhou, Jiangsu
- the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhengming Jin
- Email: jinzhengming519519@163.com
- Phone: +86 0512 67781856
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.