A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender;

• ECOG 0-1; IPI score ≤ 3 points;

• Expected survival period of more than 3 months;

• DLBCL diagnosed by tissue biopsy pathology;

• No contraindications for chemotherapy (blood and physiological examination results within 7 days), absolute neutrophil count ≥ 1.0 × 10 \^ 9/L, PLT ≥ 75 × 10 \^ 9/L, hemoglobin ≥ 80g/L (excluding patients with lymphoma bone marrow infiltration);

• According to the RECIST criteria, there must be at least one measurable lesion. For intranodal lesions, it is defined as: long diameter ≥ 1.5cm and short diameter ≥ 1.0cm; For extranodal lesions, the length and diameter should be ≥ 1.0cm;

• Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN;

• Renal function: serum creatinine ≤ 1.5 × ULN;

• No other serious illnesses that conflict with this plan;

⁃ Excluding other major illnesses, the heart function is normal;

⁃ There are no other related treatments including traditional Chinese medicine (anti-tumor effects), immunotherapy, or biologic therapy (except for treatment of bone metastasis and other symptoms);

⁃ The subjects voluntarily participate in the clinical trial, sign an informed consent form, and cooperate with follow-up;

⁃ During this treatment period, if other anti-tumor drugs are not used simultaneously, bisphosphonates can be used for bone metastasis treatment and other symptomatic treatments;

Locations
Other Locations
China
Oncology Department of The First Affilliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Mingzhi Zhang, Doctor
Mingzhi_zhang@126.com
13838565629
Backup
Lei Zhang, Doctor
13525533696
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 80
Treatments
Experimental: Elderly patients with newly diagnosed DLBCL
Obutinib or Decitabine with Rituximab, Compound Cyclophosphamide Tablets and Prednisone
Sponsors
Leads: Mingzhi Zhang

This content was sourced from clinicaltrials.gov