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

NCT06683885•Mingzhi Zhang

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

Detailed Description

This study adopts an open, single arm, prospective clinical collaborative research approach. And the aim is to observe the efficacy and safety of the combination therapy of Obutinib or Desitabine with Rituximab and Cyclophosphamide in elderly patients with newly diagnosed diffuse large B-cell lymphoma.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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 illnesses, the heart function is normal;
+3 more criteria

Exclusion Criteria

•1. 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;
•2. 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);
•3. Systemic autoimmune diseases or immunodeficiency;
•4. Refusing to collect blood samples;
•5. Allergic to any medication in the plan;
•6. Pregnant and lactating women;
•7. Major diseases that can cause experimental interference and uncontrolled active infections;
•8. Primary or secondary central tumors;
•9. Chemotherapy contraindications;
•10. Within 28 days of using Rituximab/Obutinib/Compound Cyclophosphamide Tablets/Azacitidine;
+6 more criteria

Locations (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

November 20, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

November 12, 2024

Enrollment

ESTIMATED participants

Conditions

Newly Diagnosed Diffuse Large B-cell Lymphoma

Interventions

Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone

DRUG

Contacts

Mingzhi Zhang, Doctor

CONTACT

13838565629 Mingzhi_zhang@126.com

Lei Zhang, Doctor

CONTACT

13525533696