Chidamide with Rituximab and lenalidomide for relapsed/refractory diffuse large B cell lymphoma, a multi-center, prospective, single arm, open label phase II trial

Chidamide with Rituximab and lenalidomide for relapsed/refractory diffuse large B cell lymphoma, a multi-center, prospective, single arm, open label phase II trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024918

Enrollment

Unknown

Registered

2019-08-03

Start date

2019-08-13

Completion date

Unknown

Last updated

2019-08-27

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:treatment with chidamide, lenalidomide and rituximab

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically diagnosed as diffuse large B cell lymphoma, CD20 positive, received 2 or more different regimens prior to enrollment, but did not achieve remission, or relapsed after remission; 2. aged 18-75 years; 3. ECOG status of 0, 1, or 2; 4. Life expectancy>=6 months; 5. Patient or his/her representative should be able to provide written consent before any special examination or procedure.

Exclusion criteria

Exclusion criteria: 1. Previous history of autologous stem cell transplantation; 2. History of other malignant tumors, except skin basal cell carcinoma and cervical in situ cancer; 3. Patient has other tumors at the time of enrollment; 4. With uncontrolled cardiovascular disease, coagulative disease, connective tissue disease, severe infections; 5. Primary central nervous system (CNS) lymphoma; 6. Left ventricular ejection ratio <=50%; 7. Lab tests results at enrollment (except for those caused by lymphoma): neutrophil account<1.5*10^9/L; platelet<75*10^9/L; ALT/AST higher than twice of the normal maximum value; AKP and bilirubin higher than 1.5 times of the normal maximum value; creatinin higher than 1.5 times of the normal maximum value; 8. Other conditions that investigators thinks may influence the medical condition of the enrolled patients; 9. Patients with mental disorders or those who can not comply with the research protocol; 10. Female patients during pregnancy or lactation; 11. Patients with HIV infection; 12. For HbsAg positive patients, HBV-DNA should be tested, and only HBV-DNA negative patients could be enrolled. For HBsAg negative, HBcAb positive patients, HBV DNA should also be tested, and only HBV-DNA negative patients could be enrolled.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate;	—

Countries

China

Contacts

Public ContactLuqun Wang

Qilu Hospital of Shandong University

drwangluqun@126.com+86 18560086990

Outcome results

None listed

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