Phase 2 Study of Anlotinib Combined with Rituximab, Gemcitabine, and Oxaliplatin for Early Relapsed or Refractory Diffuse Large B-cell Lymphoma

What this Trial Is About

Diffuse large B-cell lymphoma DLBCL is the most common subtype of lymphoma and represents a challenging and diverse type of cancer. Patients who experience early relapse within 12 months after diagnosis or first-line treatment, or those whose disease does not respond to initial therapy, have a particularly poor outlook. This trial aims to assess the safety and effectiveness of combining anlotinib with rituximab, gemcitabine, and oxaliplatin A-RGEMOX to treat early relapsed or refractory DLBCL, addressing the urgent need for better treatment options in this group. Participants will receive the A-RGEMOX regimen in 21-day cycles, with a total of six cycles planned. Treatment includes anlotinib taken orally at 12mg daily from day 1 to 14, rituximab administered at 375mgm2 on day 1, gemcitabine given at 1000mgm2 on days 1 and 8, and oxaliplatin at 130mgm2 on day 1. For patients aged 75 or older, dose adjustments may be made based on the investigators decision to maintain safety. This combination therapy is being studied to see if it improves response rates and supports further treatment options like stem cell transplantation. During the trial, participants will be closely monitored through clinical assessments and imaging to evaluate their response to treatment. The main outcome measured is the complete response rate 21 days after finishing treatment. Other outcomes include overall response, progression-free survival, overall survival, and safety events tracked up to five years. Organ function, blood counts, and heart function will also be regularly checked. The study duration and follow-up ensure thorough evaluation of treatment effects and patient well-being.

A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL