Actively Recruiting
Phase II Study of Anlotinib With Rituximab, Gemcitabine and Oxaliplatin (A-RGEMOX) for Early Relapsed/Refractory Diffuse Large B-cell Lymphoma
Led by Zhejiang Cancer Hospital · Updated on 2024-06-25
41
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 375mg/m2 on day 1, gemcitabine given at 1000mg/m2 on days 1 and 8, and oxaliplatin at 130mg/m2 on day 1. For patients aged 75 or older, dose adjustments may be made based on the investigator's 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.
CONDITIONS
Brief Title
A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older with ECOG score 2 or less
- Diagnosed with diffuse large B-cell lymphoma or related high-grade B-cell lymphoma types
- Early relapse within 12 months after first-line therapy or refractory to first-line treatment
- Have at least one measurable or evaluable lymphoma lesion
- Adequate organ and bone marrow function as defined by blood counts and liver, kidney, and coagulation tests
- Left ventricular ejection fraction 50% or greater
- Negative pregnancy test and use effective contraception during study and for 6 months after
- Life expectancy greater than 3 months
You will not qualify if you...
- Primary central nervous system or primary mediastinal large B-cell lymphoma
- Hemophagocytic syndrome at diagnosis
- Central nervous system involvement from lymphoma
- Participation in another clinical trial or treatment with study drug less than 4 weeks ago
- History of other active cancers within 2 years except certain treated skin or cervical cancers
- HIV infection or AIDS; specific hepatitis B or C viral load limits apply
- Major surgery within 28 days before study start
- Active infections needing systemic therapy within 14 days before treatment
- Severe or uncontrolled diseases including heart failure, uncontrolled hypertension, active ulcers, or bleeding disorders
- Recent stroke or brain hemorrhage within 6 months
- Deep vein thrombosis or pulmonary embolism within past 12 months
- Requirement for antiplatelet and anticoagulant drugs without alternatives
- Use of strong CYP1A2 or CYP3A inhibitors or inducers within 7 days before treatment
- Known allergy to study drugs
- Deemed unsuitable by investigators for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive the A-RGEMOX drug regimen consisting of Anlotinib, Rituximab, gemcitabine, and oxaliplatin in 21-day cycles for up to 6 cycles. Dose adjustments may be made for participants aged 75 or older.
At least 6 treatment visits (in-person), with medication taken daily as prescribed
Duration - 30 days
Participants are monitored for safety and treatment effects for 30 days after the last treatment dose.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
X
Xi Chen
H
Haiyan Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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