The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL i… (NCT05018520) | Clinical Trial Compass
RecruitingPhase 3
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
China640 participantsStarted 2021-09-17
Plain-language summary
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
Who can participate
Age range14 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
* Treatment naïve
* IPI=0,1
* Age ≥ 14 or ≤75 years
* non-mass (The length of the lesion\<7.5cm)
* ECOG=0,1
* Life expectancy\>6 months
* Informed consented
Exclusion Criteria:
* Have received systemic or local treatment including chemotherapy in the past
* Have received autologous stem cell transplantation in the past
* Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
* Primary skin, primary central nervous system lymphoma
* Left ventricular ejection fraction ≦50%
* Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision
* Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils \<1.5\*109/L Platelet\<80\*109/L Hemoglobin \<100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal
* Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
* Pregnant or…
What they're measuring
1
Progression of disease within 24 months
Timeframe: Baseline up to data cut-off (up to approximately 24 months)