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NCT06701357RecruitingPhase 2

CR-CHOP+X in Previously Untreated DEL

A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.

Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
49 (estimated)
First submitted
21 Nov 2024
Start date
10 Dec 2024
Primary completion date
1 Dec 2026
Lead sponsor
Ruijin Hospital
NCT number
NCT06701357

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 49
  • From 10 Dec 2024 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Have previously received systemic or local treatment including chemotherapy;
  • 2\. Previously received autologous stem cell transplantation;
  • 8\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study;

Other illness

  • 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;
  • 9\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
  • 11\. People living with HIV;
  • 12\. 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.

Lab values

  • 6\. Left ventricular ejection fraction ≤ 50%;
  • 7\. Laboratory test values at the time of screening (unless due to lymphoma): A. Neutrophils \<1.5\*109/L; B. Platelet \<75\*109/L; C. 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; D. Creatinine levels higher than 1.5 times the upper limit of normal;

Other

  • 5\. Primary central nervous system lymphoma;
  • 10\. Pregnant or lactating women;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.