A single arm study for doxorubicin hydrochloride liposome combined with lenalidomide, rituximab and dexamethasone in the treatment of elderly with diffuse large B-cell lymphoma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000028715

Enrollment

Unknown

Registered

2020-01-01

Start date

2020-01-01

Completion date

Unknown

Last updated

2020-01-06

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

Conditions

lymphoma

Interventions

experimental group: doxorubicin hydrochloride liposome combined with lenalidomide, rituximab and dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathology: histologically confirmed primary diffuse large B-cell lymphoma; 2. Aged >65 years old; 3. ECOG of Eastern oncology cooperation group 0-2; 4. At least one measurable lesion which intranodal lesions length >1.5cm; extranodal lesions length >1.0cm; 5. The estimated survival is over six months; 6. Liver function: AST and alt =3.0x10^9/L, ANC >=1.5x10^9/L, PLT >=75x10^9/L, Hb>=90g/L; 9. Cardiac function: LVEF >=55% 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. It has the 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

Measure	Time frame
complete remission;	—

Secondary

Measure	Time frame
Objective response rate;overall survival;	—

Countries

China

Contacts

Public ContactYao Liu

The Second Affiliated Hospital of Army Medical University

648283926@qq.com+86 13228684685

Outcome results

None listed

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