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Clinical study of jianpiyishen granules and Western medicine in the treatment of fragile DLBCL in the elderly

Clinical study of jianpiyishen granules and Western medicine in the treatment of fragile DLBCL in the elderly

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2022000101
Enrollment
Unknown
Registered
2022-10-06
Start date
2022-10-20
Completion date
Unknown
Last updated
2023-02-20

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

test group:Conventional chemotherapy and jianpiyishen granules

Sponsors

Guang'anmen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients with CD20-positive initial treatment of large B-cell lymphoma with pathological diagnosis; 2. Age = 60 years old, male or female; 3. Ann Arbor/Cotswords Phase I-IV; 4. CGA assessment of patients before treatment, and elderly vulnerable patients who are not suitable for standardized therapy must meet one of the following criteria: 1) ADL in the MCIRS-G score; 4) Patients with an age = 80 years old need to meet: ADL =5, or IADL =7, or 0-1 in the MCIRS-G score of grade 3 to 4 (or > 5 grade 2 complications); 5. The expected survival period is more than 6 months; 6. Alanine aminotransferase (AST)= 2.5×ULN, alanine aminotransferase (ALT)=2.5×ULN, serum creatinine Cr=1.5×ULN; 7. Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have a previous history of blood or non-hematologic tumors undergoing chemoradiotherapy; 2. In the past 5 years, there is a history of malignant tumors other than skin squamous cell carcinoma, skin basal cell carcinoma, and cervical carcinoma in situ; 3. Patients with central nervous system involvement; 4. There is a serious infection that is not controlled; 5. Have other uncontrolled diseases and the researcher believes that it is not suitable for joiners; 6. Participating in other clinical studies; 7. Persons infected with COVID-19(excluding cured patients); 8. Patients with poor adherence.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
mPFS;EORTC QLQ-C30 scale;mOS;IADL scale;

Countries

China

Contacts

Public ContactWujie
wujielily@163.com13522635803

Outcome results

None listed

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