← Back to Clinical Trials
Recruiting Phase 1, Phase 2 NCT06683885

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

Trial Parameters

Condition Newly Diagnosed Diffuse Large B-cell Lymphoma
Sponsor Mingzhi Zhang
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 80
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-11-20
Completion 2026-05-01
Interventions
Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone

Brief 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 Criteria

Inclusion Criteria: 1. Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender; 2. ECOG 0-1; IPI score ≤ 3 points; 3. Expected survival period of more than 3 months; 4. DLBCL diagnosed by tissue biopsy pathology; 5. 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); 6. 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; 7. Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN; 8. Renal function: serum creatinine ≤ 1.5 × ULN; 9. No other serious illnesses that conflict with this plan; 10. Excluding other major

Related Trials