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R-CDOP regimen for newly diagnosed diffuse large B cell lymphoma: a single-arm, multi-center, prospective study

R-CDOP regimen for newly diagnosed diffuse large B cell lymphoma: a single-arm, multi-center, prospective study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044994
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-02

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

Case series:The study group used R-CDOP regimen.

Sponsors

Department of Hematology, Shanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed by histopathology as a newly treated patient with diffuse large B-cell lymphoma; 2. Aged 18 to 80 years ; 3. ECOG of Eastern oncology cooperation group 0-2; 4. The estimated survival >= 3 months; 5. At least one measurable lesion which intranodal lesions length >=1.5cm; extranodal lesions length >1.0cm; 6. Blood routine test: WBC >= 3.0 x 10^9/L, ANC >= 1.5 x 10^9/L, PLT >= 75 x 10^9/L, Hb >= 90g/L; 7. Liver function: AST and alt = 50% by echocardiography; 10. NYHA heart function was classified as grade I; 11. Understand and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. With primary or secondary central nervous system involvement; 2. Serious heart disease or discomfort, including but not limited to: (1) Significant ventricular arrhythmia or higher-level atrioventricular block (type 2 [mobitz 2]or third degree atrioventricular block); (2) Unstable angina; (3) Valvular disease with clinical significance; (4) Transmural myocardial infarction on ECG; (5) Uncontrolled hypertension; 3. Have a clear history of interstitial pneumonia, allergic asthma or serious allergic diseases; 4. Have other tumor history, except for the cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, etc; 5. HIV infected persons (HIV antibody positive); 6. Patients with acute or chronic active hepatitis B (HBsAg positive, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negative acceptable; HCV antibody positive, HCV RNA negative acceptable); 7. Pregnant or lactating women; 8. Patients who have received organ transplantation before; 9. Serious infection in active period or poor clinical control; 10. With contraindications of high dose hormone, Such as uncontrollable hyperglycemia, gastric ulcer or mental illness, etc; 11. Have a serious neurological or psychiatric history, including dementia or epilepsy; 12. Patients can not be enrolled which will be judged by the researchers.

Design outcomes

Primary

MeasureTime frame
objective response rate, ORR;

Secondary

MeasureTime frame
Cardiotoxicity;2 years progression free survival;2 years overall survival rate;Degree and incidence of other adverse events;

Countries

China

Contacts

Public ContactSu Liping

Shanxi Provincial Cancer Hospital

sulp2005@sohu.com+86 13835158122

Outcome results

None listed

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