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Clinical study of lenalidomide in maintenance therapy of diffuse large B cell lymphoma

Clinical study of lenalidomide in maintenance therapy of diffuse large B cell lymphoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045538
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-29

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:lenalidomide

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.DLBCL patients with CR/PR after 6-8 cycles of R-CHOP (or other regimens such as R-DA-EPOCH) (including patients undergoing autologous hematopoietic stem cell transplantation after first-line treatment remission); 2.IPI score: age > 60 years old, IPI >= 3 points; Age = 2 points; 3.Aged >= 18 years; 4.ECOG PS = 30ml/min; 6.Platelet count >= 50 x 10^9/L; 7.Absolute neutrophils count >= 1.0 x 10^9/L; 8.Expected survival>= 6 months; 9.Fertile subjects (male or female) should take effective medical contraception during the study period and within 6 months after the end of treatment; 10.Signed the informed consent; 11.Good compliance, family members agree to cooperate with the survival follow-up.

Exclusion criteria

Exclusion criteria: 1.Positive for HCV antibody, Treponema pallidum antibody and HIV antibody; 2.Lymphoma involving the central nervous system or meninges; 3.History of other malignant tumors, unless disease-free >= 5 years; 4.Unwillingness to perform VTE prophylaxis; 5.Pregnant or lactating women; 6.Severe active infection; 7.A history of serious neurological or psychiatric problems, including dementia or epilepsy; 8.Participated in other drug clinical trials within four weeks; 9.A variety of factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 10.Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
overall survival;drug safety;

Countries

china

Contacts

Public ContactHua Haiying

Affiliated Hospital of Jiangnan University

huahy007@163.com+86 15301516125

Outcome results

None listed

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