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

Phase 1

• Conditions: Diffuse Large B-Cell Lymphoma

• Registration Number: ITMCTR2022000101
• Lead Sponsor: Guang'anmen Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 < 5 points; 2) IADL < 6 points; 3) 1 grade 3 to 4 comorbidities (or 8 grade 2 comorbidities> 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

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR;

Secondary Outcome Measures

Name	Time	Method
mPFS;EORTC QLQ-C30 scale;mOS;IADL scale;