NCT07348575
Enrolling By Invitation
Phase 3
A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma
Second Affiliated Hospital of Nanchang University1 site in 1 country80 target enrollmentStarted: July 1, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Enrolling By Invitation
- Sponsor
- Second Affiliated Hospital of Nanchang University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 2-year progression-free survival
Overview
Brief Summary
This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL).
Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Initial treatment of diffuse large B-cell lymphoma (DLBCL) confirmed by tumor histopathology with at least one lesion on either axis More than 1.5 cm, sufficient specimens for second-generation sequencing or single-cell sequencing;
- •Age \> 18 years old, \< 80 years old, gender unlimited;
- •EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml;
- •Patients judged by the investigator to have a life expectancy of at least 6 months;
- •The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
- •Signed written informed consent before screening.
Exclusion Criteria
- •Have previously received systemic or local treatment including chemotherapy;
- •Previously received autologous stem cell transplantation;
- •Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases;
- •Lymphoma involves the central nervous system;
- •Primary mediastinal large B-cell lymphoma;
- •Left ventricular ejection fraction \< 50%;
- •Laboratory test values at the time of screening: (unless due to lymphoma);
- •Neutrophils \< 1.5 x 109/L;
- •Platelet \< 75 x 109/L;
Arms & Interventions
Decitabine in combination with R-CHOP
Experimental
Decitabine in combination with R-CHOP
Intervention: Decitabine in combination with R-CHOP (Drug)
R-CHOP
Active Comparator
R-CHOP
Intervention: R-CHOP (Drug)
Outcomes
Primary Outcomes
2-year progression-free survival
Time Frame: 2 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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