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Recruiting Phase 3

The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

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About this study

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

Condition
Diffuse Large B Cell Lymphoma
Tested
Six Courses of R-CHOP Plus Two Courses of Rituximab, Four Courses of R-CHOP Plus Four Courses of Rituximab
Sponsor
Ruijin Hospital

Who can join

Age
14 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 14 years
  • Maximum age: 75 years
  • Study condition: Diffuse Large B Cell Lymphoma
  • 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 15

  • 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 lactating women
  • Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative.
  • In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
  • Patients living with HIV
  • Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening

Where

1 site, 1 recruiting

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.