Skip to content

A prospective, multicenter, randomized,double-blind study of mabthera adjuvant therapy in treating ocular adnexal lymphomas

A study of mabthera adjuvant therapy in treating ocular adnexal lymphomas

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006457
Enrollment
Unknown
Registered
2015-05-28
Start date
2015-06-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ocular adnexal lymphoma

Interventions

Low-grade malignant patient :Local radiotherapy and mabthera
Low grade control group :Local radiotherapy and placebo
High-grade malignant patient :CHOP chemotherapy and mabthera
High grade control group:CHOP chemotherapy and local radiotherapy

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. surgical biopsy confirmed of ocular adnexal B cell lymphoma, CD20+, and all biopsy specimen should be sent to Shanghai ninth hospital to clarify its pathological types. Ocular adnexal should be the primary lesion. If the lymphoma has involved the whole body in the past, the ocular adnexal should be the only recurrence; 2. The lymphoma in the stage of IE or IIE; 3. Age >14; 4. The blood routine examination, liver and kidney function is normal (WBC>=3.5*10^9/L, Hb>100 g/L, PLT>90*10^12/L); 5. Women of childbearing age should be with negative blood and urine pregnancy test, no lactation, patients need to take effective contraceptive measures during treatment; 6. ECOG behavior status of 0, 1, 2 level; 7. willing to take part in the clinical trial and sign the informed consent form. VIII. Is willing to have these tumor sites surgically removed and do the follow up accordingly.

Exclusion criteria

Exclusion criteria: 1. The diagnosis is not clear; 2. The bone marrow of patients have been damaged, including: (1) Received bone marrow suppression therapy such as autologous bone marrow transplantation or peripheral blood stem cell rescue; (2) PLT <100000 cells/mm3; (3) Bone marrow cells reduced more than 15%; (4) One or more bone marrow precursor cells reduced. (granulocyte, giant nuclear cell lines, red blood cells); 3. The primary lesions or recurrence that has been previously treated; 4. Lymphoma not from the ocular adnexal and sentinel lymph node system; 5. The lymphoma patients with AIDS; 6. Patients whoes cardiopulmonary function is insufficient and cannot tolerate radiation and chemotherapy; 7. patients with liver and kidney dysfunction; 8. Patients with serious infection or organic disease; 9. lactation or pregnancy women; 10. Having a history of any other malignant tumor; 11. Having clinical symptoms of brain dysfunction and severe mental illness; 12. Having major surgery within four weeks; 13. Not willing to sign informed consent; 14. Patients whoes treatment and follow-up requirement can not be completed.

Design outcomes

Primary

MeasureTime frame
Cure rate;Response rate;Recurrence rate;survival rate;

Countries

China

Contacts

Public ContactFan xianqun
Fanxq@sh163.net+86 13818567505

Outcome results

None listed

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