Skip to content

A prospective, single-arm, phase II, multi-center clinical study of zanubrutinib combined with rituximab and lenalidomide in the treatment of relapsed/refractory primary central nervous system lymphoma

A prospective, single-arm, phase II, multi-center clinical study of zanubrutinib combined with rituximab and lenalidomide in the treatment of relapsed/refractory primary central nervous system lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046986
Enrollment
Unknown
Registered
2021-06-06
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed/refractory primary central nervous system lymphoma

Interventions

experimental group:Zebutinib, rituximab, and lenalidomide combined regimen treatment

Sponsors

The Affiliated Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Histopathologically diagnosed as non-GCB primary central nervous system lymphoma; 3. Patient received no less than one chemotherapy regimen, such as single agent HD-MTX or MTX combined treatments; 4. Disease progression proved by imagine examination 21 days before registration; 5. ECOG PS 0-2 points; 6. Patient fulfilled the following criteria 21 days before registration: neutrophils >=1.0 x 10^9/L or platelets >=75 x 10^9/L and hemoglobin >=8 g / dL without transfusion; total bilirubin <= 1.5 times of normal maximum, AST or ALT <= 3 times of normal maximum; INR or APTT <= 1.5 times of normal maximum; renal dysfunction with creatinine <= 2 times of normal maximum; 7.Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after last dose; 8. Willing to sign the written consent.

Exclusion criteria

Exclusion criteria: 1. The patient is using other approved or researched anti-tumor drugs at the same time; 2. Before starting the study drug, the patient has received chemotherapy, monoclonal antibody or targeted anti-cancer therapy for =5 mIU/mL; 18. The patient has received allogeneic stem cell transplantation (autologous stem cell transplantation is not excluded); 19. The patient is unwell or unable to participate in all necessary research evaluations and procedures.

Design outcomes

Primary

MeasureTime frame
Overall response rate;Adverse effects;Progression free survival;Overall survival;

Countries

China

Contacts

Public ContactShi Wenyu

The Affiliated Hospital of Nantong University

shiwenyu@hotmail.com+86 13515203737

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026