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A multicenter, prospective, non-random cohort study of BR± lenalidomide in the treatment of newly treated indolent B-cell lymphoma and elderly mantle cell lymphoma

A multicenter, prospective, non-random cohort study of BR±lenalidomide in the treatment of newly treated indolent B-cell lymphoma and elderly mantle cell lymphoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056288
Enrollment
Unknown
Registered
2022-02-03
Start date
2021-04-02
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

lymphoma

Interventions

Experimental group vs. control group:lenalidomide vs. non lenalidomide treatment

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients who are diagnosed as CD20+ B-cell lymphoma (including FL, MZL, MCL), meet their respective diagnostic criteria, or are clearly indolent B-cell lymphoma but cannot be accurately typed (B-LPDu); for MCL Requires age >= 65 years old, or although 10.0cm) or huge spleen ( >= 6cm below the left costal margin); (4) Those with systemic symptoms: continuous two weeks/repeated fever (above 38?) and not caused by infection, or night sweats, or weight loss > 10% within 6 months; (5) The disease progresses rapidly, such as the doubling time of the absolute value of peripheral blood lymphocytes < 6 months, and/or the rapid decrease of hemoglobin or platelets caused by non-autoimmune reasons; (6) Meet the treatment indications of other subtypes. 5. Eastern Cooperative Oncology Group (ECOG) performance status <= 2; 6. At least 3 months expected survival.

Exclusion criteria

Exclusion criteria: 1. Malignant tumors other than B-NHL (including active central nervous system lymphoma) have been diagnosed or treated in the past year; 2. There is clinical evidence that large cell lymphoma has transformed or progressed to prolymphocytic lymphocytic leukemia (PLL); 3. Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT) > 3 upper limit of normal (ULN), aspartate aminotransferase (AST) > 3 × ULN, total bilirubin (TBIL) > 2 × ULN, blood creatinine>1.5 × ULN; 4. Other serious medical diseases will affect the research (such as uncontrolled diabetes, gastric ulcer, other serious heart and lung diseases, etc.). The right to make judgments belongs to the researcher; 5. Severe or uncontrolled infection; 6. Central nervous system dysfunction with clinical manifestations; 7. The patient has undergone major surgery in the past 30 days (not including lymph node biopsy); 8. Women during pregnancy or lactation, women of childbearing age who have not taken contraceptive measures; 9. Allergic to the drugs used.

Design outcomes

Primary

MeasureTime frame
overall response rate, ORR;

Secondary

MeasureTime frame
progression-free survival, PFS;complete response Rate, CRR;Duration of Response, DoR;

Countries

china

Contacts

Public ContactLi zengjun

Shandong Cancer Hospital

Zengjunli@163.com+86 136 4213 8692

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026