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Recruiting Phase 2

CR-CHOP+X in Previously Untreated DEL

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About this study

This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.

Condition
DLBCL
Tested
CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib, CR-CHOP + decitabine
Sponsor
Ruijin Hospital

Who can join

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

Inclusion 11

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: DLBCL
  • 1\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
  • 2\. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%;
  • 3\. Age ≥ 18 years old, ≦75 years old;
  • 4\. ECOG physical status score of 0, 1 or 2;
  • 5\. No previous history of malignant tumors; No other tumors occurred simultaneously;
  • 6\. Patients judged by the investigator to have a life expectancy of at least 6 months;
  • 7\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure;
  • 8\. International prognostic Index (IPI) \>1 score.

Exclusion 18

  • 1\. Have previously received systemic or local treatment including chemotherapy;
  • 2\. Previously received autologous stem cell transplantation;
  • 3\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
  • 4\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
  • 5\. Primary central nervous system lymphoma;
  • 6\. Left ventricular ejection fraction ≤ 50%;
  • Laboratory test values at the time of screening (unless due to lymphoma): A.
  • Neutrophils \<1.5\*109/L;
  • Platelet \<75\*109/L;
  • ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal;
  • Creatinine levels higher than 1.5 times the upper limit of normal;
  • 8\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study;
  • 9\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
  • 10\. Pregnant or lactating women;
  • 11\. People living with HIV;
  • Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative.
  • In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed.
  • If the result is positive, the treatment should also be negative before admission.

Where

1 site, 1 recruiting

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

Recruiting

Contact

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