Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years

Diffuse Large B Cell Lymphoma Clinical Trial

— R2DLBCL80  

Official title:

Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622579
• Other study ID #: 2020099H
• Status: Recruiting
• Phase: Phase 2
• Start date: October 23, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Xinmiao Jiang
• Phone: (+86)20-83827812
• Email: 296260860[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

1. Age?80 years ;

2. ECOG score 0-2;

3. untreated with pathologically con?rmed CD20+ DLBCL ;

4. expected life expectancy of = 12 weeks;

5. capable of swallowing tablets;

6. GFR(by Cockcroft- Gault)=30 ml/min;

7. can sign written informed consent to participate in the study.

Exclusion Criteria:

1. with CNS involvement;

2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for =5 years can enter this study;

3. with = grade 2 peripheral neurophathy;

4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;

5. received live vaccine within 28 days.;

6. HIV-positive;

7. thrombosis ;

8. GFR<30 mL/min;

9. other conditions not suitable for rituximab or lenalidomide application.

Related Conditions & MeSH terms

• Age Over 80 Years
• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• lenalidomide combined with rituximab
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.

Locations

Country	Name	City	State
China	Guangdong provincial people's hospital	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Foshan First People's Hospital, Guangzhou First People's Hospital, Huizhou Municipal Central Hospital, Shantou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Overall response rate	24 months
Secondary	CR	Complete response	24 months
Secondary	OS	Overall survival	from date of treatment until the date of death from any cause, assessed up to 5 years
Secondary	PFS	Progression-free survival	from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years