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Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years (R2DLBCL80)

Primary Purpose

Diffuse Large B Cell Lymphoma, Age Over 80 Years

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
lenalidomide combined with rituximab
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring lenalidomide

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age≧80 years ;
  2. ECOG score 0-2；
  3. untreated with pathologically confirmed 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.

Sites / Locations

  • Guangdong provincial people's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lenalidomide combined with rituximab

Arm Description

Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.

Outcomes

Primary Outcome Measures

ORR
Overall response rate

Secondary Outcome Measures

CR
Complete response
OS
Overall survival
PFS
Progression-free survival

Full Information

First Posted
November 5, 2020
Last Updated
November 5, 2020
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Guangzhou First People's Hospital, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, Shantou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04622579
Brief Title
Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years
Acronym
R2DLBCL80
Official Title
Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Guangzhou First People's Hospital, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, Shantou Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma, Age Over 80 Years
Keywords
lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lenalidomide combined with rituximab
Arm Type
Experimental
Arm Description
Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.
Intervention Type
Drug
Intervention Name(s)
lenalidomide combined with rituximab
Intervention Description
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
Primary Outcome Measure Information:
Title
ORR
Description
Overall response rate
Time Frame
24 months
Secondary Outcome Measure Information:
Title
CR
Description
Complete response
Time Frame
24 months
Title
OS
Description
Overall survival
Time Frame
from date of treatment until the date of death from any cause, assessed up to 5 years
Title
PFS
Description
Progression-free survival
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≧80 years ; ECOG score 0-2； untreated with pathologically confirmed CD20+ DLBCL ; expected life expectancy of ≥ 12 weeks; capable of swallowing tablets; GFR(by Cockcroft- Gault)≥30 ml/min; can sign written informed consent to participate in the study. Exclusion Criteria: with CNS involvement; 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; with ≥ grade 2 peripheral neurophathy; with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks; received live vaccine within 28 days.; HIV-positive; thrombosis ; GFR<30 mL/min; other conditions not suitable for rituximab or lenalidomide application.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinmiao Jiang
Phone
（+86）20-83827812
Email
296260860@qq.com
Facility Information:
Facility Name
Guangdong provincial people's hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmiao Jiang
Phone
+86 20 81884713-80631
Email
296260860@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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