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
Study ID
NCT06683885
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Newly Diagnosed Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone — DRUG
    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.

Study Details

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

Key Dates

Start date
Nov 20, 2024
Status verified
Nov 2024
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elderly patients with newly diagnosed DLBCL
    Obutinib or Decitabine with Rituximab, Compound Cyclophosphamide Tablets and Prednisone

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: two years ]

Central Contacts