Observational study of R2 chop (lenalidomide, rituximab, cyclophosphamide, doxorubicin, vindesine / vinorelbine and prednisone) in the first-line treatment of high-risk / high-risk DLBCL

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100043079

Enrollment

Unknown

Registered

2021-02-04

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-05-24

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

Conditions

DLBCL

Interventions

R2-CHOP:Lenalidomide, 25mg, orally on day 1-14

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Subjects meeting all of the following criteria will be included in this study: (1) Nccn-ipi > 3 Project score Age > 40 to 1 to 3 2 Ann Arbor stage III-IV 1 Extranodal involvement (involving bone marrow, CNS, liver / GI tract, lung) 1 PS score >= 2 1 Risk group: Low risk group 0-1 Low risk group 2-3 High risk group 4-5 High risk group >= 6 (2) No previous treatment and no other treatment can be considered as lymphoma treatment drugs; (3) No central nervous system lymphoma (CNS) or cerebrospinal fluid involvement of malignant lymphoma cells; (4) No history of myocardial infarction (= 25%; (10) Patients must have measurable disease (at least one lesion larger than 1.5cm in diameter), which can be measured by CT or PET-CT; (11) Ejection fraction >= 45% by MUGA or echocardiography; (12) There are no comorbid systemic diseases or other serious complications that, in the judgment of the investigators, make the patient unfit for the study, or seriously interfere with the proper assessment of the safety and toxicity of the prescribed protocol, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia or psychosis Disease / social status; (13) Neutrophil count (ANC) >= 150 * 10^9 / L; (14) Platelet count (PLT) >= 100 * 10^9 / L; (15) Total bilirubin 1.5 x ULN, direct bilirubin must be normal; (16) Alkaline phosphatase (ALK) 30 ml / min; (19) Fertile women must have birth control 10-14 days before starting lenalidomide; (20) Fertile men must have effective birth control.

Exclusion criteria

Exclusion criteria: (1) The patient was treated with EPO; (2) Pregnant or lactating women; (3) Patients allergic to any component of the protocol; (4) Exclusion of patients with stage I and II non mass disease; (5) Patients who could not or did not receive any anticoagulant prophylaxis were excluded.

Design outcomes

Primary

Measure	Time frame
ORR;CR;	—

Countries

China

Contacts

Public ContactYun Zeng

The First Affiliated Hospital of Kunming Medical University

13888112822@163.com+86 13888112822

Outcome results

None listed

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