New treatment for previously untreated diffuse large B-cell lymphoma

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.

This study tests a new combination treatment for people with newly diagnosed double-expression lymphoma to see if it works better based on their genetic makeup.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, orelabrutinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06701357 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of a combination treatment called CR-CHOP, which is administered alongside targeted drugs tailored to different genetic subtypes in patients with newly diagnosed double-expression lymphoma. Participants receive one course of CR-CHOP followed by additional cycles based on their genetic profile, with ongoing evaluations to assess treatment effectiveness. The study aims to determine the best treatment approach for patients with specific molecular characteristics of their lymphoma.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed diffuse large B-cell lymphoma exhibiting specific genetic markers.

Not a fit: Patients who have previously received any form of systemic treatment or have other concurrent malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and personalized approach for patients with diffuse large B-cell lymphoma.

How similar studies have performed: Other studies have shown promise with targeted therapies in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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%;
* 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;
* 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;
* 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.

Where this trial is running

Shanghai, Shanghai Municipality

• No. 197 Ruijin 2nd Road, Huangpu District, Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li Wang

Conditions DLBCL; double-expression; chidamide