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Randomized Controlled Trial on the Maintenance Treatment of Elderly Patients with Diffuse Large B-Cell Lymphoma Using Chinese Herbal Qinhuang Formula

Randomized Controlled Trial on the Maintenance Treatment of Elderly Patients with Diffuse Large B-Cell Lymphoma Using Chinese Herbal Qinhuang Formula

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090671
Enrollment
Unknown
Registered
2024-10-11
Start date
2024-01-29
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Experimental Group:take Qinhuang Formula

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: Eligibility criteria for study participants: (1) Patients with pathologically confirmed CD20+ B-cell lymphoma (including de novo DLBCL, transformed DLBCL, or follicular lymphoma stage 3B); (2) Age of patients > 60; achieving complete remission (CR) or partial remission (PR) after first-line treatment with anthracycline and rituximab; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3; (4) International Prognostic Index (IPI) at diagnosis > 2; (5) Signed written informed consent.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this study: (1)Involvement of the central nervous system; (2)Liver function transaminase levels more than 3 times the upper limit of normal, bilirubin levels more than 2.5 times the upper limit of normal, serum creatinine levels more than 2 times the upper limit of normal; (3)Severe cardiac, pulmonary, neurological, and endocrine system diseases; (4)History of organ transplantation or other forms of immunosuppression; (5)HIV infection or other malignant tumors; (6)Active episode of mental illness or cognitive dysfunction.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival rate;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Score;

Countries

China

Contacts

Public ContactZhu Werirong

Department of Traditional Chinese Medicine, Ruijin Hospital, Shanghai JiaoTong University School of Medicine

willonzhu@163.com+86 21 3418 7827

Outcome results

None listed

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