Randomized open multicenter study of R-DA-EDOCH and R-CHOP as a first-line regimen with stage III-IV, double positive of CD10 and MUM1, triple negative of CD10, BCL6, MUM1 of non-germinal central B cell in de novo diffuse large B-cell lymphoma patients

Randomized open multicenter study of a comparison of R-DA-EDOCH and R-CHOP as a first-line regimen with stage III-IV, double positive of CD10 and MUM1, triple negative of CD10, BCL6, MUM1 of non-germinal central B cell in de novo diffuse large B-cell lymphoma patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900028209

Enrollment

Unknown

Registered

2019-12-15

Start date

2020-01-01

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse large B-cell lymphoma

Interventions

1:R-DA-EDOCH

2:R-CHOP

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. male or female: 18-75 years old; 2. double positive of CD10 and MUM1, triple negative of CD10, BCL6, MUM1 of non-germinal central B cell in de novo diffuse large B-cell lymphoma confirmed by pathology; 3. de novo diffuse large B-cell lymphoma; 4. stage III-IV confirmed by Lugano2014; 5. stage I-II, accompany bone marrow involvement; 6. HBV-DNA copy number = 90 g/L(without blood transfusion within 14 days); ii. neutrophil count > 1.5 x 10^9/L; iii. blood platelet count >= 100 x 10^9/L; b) biochemical test i. total bilirubin = 50ml/min; iv. coagulation function: INR <= 1.5 x ULN; APTT <= ULN-10s; c) normal cardiopulmonary function; none contraindications for chemotherapy; d) with evaluable lesion; 10. with effective contraception between treatment time and 6 months after that; 11. signed informed consent; 12. good compliance.

Exclusion criteria

Exclusion criteria: 1. With central nervous system involvement and expected life less than 6 months; 2. Uncontrolled diabetes or with contraindication of high doses of glucocorticoids; 3. History of other tumors except cured cervical cancer or skin basal cell carcinoma; 4. Active infection of HIV or syphilis; 5. Women who are pregnant or nursing; 6. Organ transplant history; 7. Severe active infection; 8. Psychiatric history; 9. Attended other clinical trial within 4 weeks; 10. Cannot be taken orally; 11. History of bleeding;bleeding events over third-degree with CTC1E4.0; 12. Uncontrolled high blood pressure with one hypertension drug,history of unstable angina pectoris,newly diagnosed angina pectoris within 3 months or myocardial infarction within 6 months,arrhythmia with long-term use of antiarrhythmic drugs; 13. Long term unhealed wound or incomplete fracture; 14. Abnormal coagulation; 15. Arteriovenous thrombosis within 6 months; 16. without effective contraception between treatment time and 6 months after that;negative pregnancy test within 7 days and not in a suckling period; 17. Thyroid dysfunction history or at present(out of control by medication); 18. History of psychiatric substance abuse; 19. Serous cavity effusion requiring intervention; 20. History of immunodeficiency; 21. Not suitable for inclusion judged by reserachers.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival;Overall Survival;Overall Response Rate;	—

Countries

China

Contacts

Public ContactXiaohong Lu

The Affiliated Hospital of Jiangnan University

drwuxiaohong@163.com+86 0510-88682108

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026