RecruitingPhase 1Phase 2NCT06683885

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

Sponsor

Mingzhi Zhang

Enrollment

80 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Diffuse Large B-cell Lymphoma

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of targeted drugs (obutinib or decitabine) with standard chemotherapy in elderly patients newly diagnosed with a type of aggressive blood cancer called Diffuse Large B-cell Lymphoma (DLBCL), who may not tolerate standard intensive chemotherapy. **You may be eligible if...** - You are 65 years or older - You have been newly diagnosed with DLBCL, confirmed by tissue biopsy - Your overall health status is rated 0–1 on the ECOG scale (generally functional) - Your blood counts, liver, and kidney function meet the required levels - You are expected to survive at least 3 more months **You may NOT be eligible if...** - You have a serious neurological or psychiatric condition - You are currently in another clinical trial - You have an active serious infection or autoimmune disease - You are allergic to any of the study medications - You are pregnant or breastfeeding - You have HIV, hepatitis B or C, or syphilis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone

For non GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Obutinib, 150mg, QD, P.O.; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Obutinib maintain treatment for 6 months. Obutinib, 150mg, QD, P.O. After 6 cycles of initial treatment, the efficacy was evaluated. For GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Decitabine, 10mg, QD，D1-5, ivgtt; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Decitabine maintenance treatment for 4 cycles, 21 days per cycle. Decitabine, 10mg, QD，D1-5, ivgtt. Evaluate the efficacy after 6 cycles of treatment.

Locations(1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06683885