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Rituximab plus Lenalidomide in elderly untreated patients with DLBCL

Rituximab plus Lenalidomide in elderly untreated patients with DLBCL: a multicentre, single-arm, phase 2 trial

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026380
Enrollment
Unknown
Registered
2019-10-05
Start date
2019-10-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

DLBCL

Interventions

single arm:Rituximab plus Lenalidomide

Sponsors

Anhui Provincial Cance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included. 2. Aged 80 to 70 years and ECOG >= 2. 3. With a minimum life expectancy of 3 months. 4. There is at least one imaging measurable lesion. 5. Having previously signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any other histological type of lymphoma. a. Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. b. Any history of treated or non-treated indolent lymphoma. 2. Central nervous system or meningeal involvement by lymphoma. 3. Major surgical procedures were performed within 14 days of treatment of DLBCL. 4. Severe and uncontrolled cardiovascular disease. 5. Poor bone marrow reserve as defined by neutrophils 2 fold ULN). 7. Poor hepatic function (total bilirubin level > 2 fold ULN, transaminases > 3 fold ULN) unless these abnormalities are related to the lymphoma. 8. Uncontrolled and active systemic fungi, bacteria, viruses or other infections. 9. HIV infection. 10. Uncontrolled and active HBV and HCV infection. 11. Situations that investigator found it inappropriate to join this trial.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
PFS;best ORR;

Countries

China

Contacts

Public ContactDing Kai Yang

Anhui Provincial Cance Hospital

dingkaiy@126.com+86 13966672170

Outcome results

None listed

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