A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab,… (NCT06683885) | Clinical Trial Compass
RecruitingPhase 1/2
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
China80 participantsStarted 2024-11-20
Plain-language 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
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. 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;
✕. Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be quit, or other substantial lesions that may increase central neurotoxicity;
✕. Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of enrollment (excluding those who have not received treatment);