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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGOverall Response Rate (ORR)
Overall Response Rate
Time frame: two years
Progression Free Survival (PFS)
Progression Free Survival
Time frame: two years
Overall Survival (OS)
Overall Survival
Time frame: two years
Disease free survival(DFS)
Disease free survival
Time frame: two years
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