Back to resultsStudy Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ibrutinib
Lenalidomide
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring iR2
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed diffuse large B cell lymphoma, treatment naive
- Age > 75 years
- Ineligible for standard chemotherapy
- Must has measurable lesion in CT or PET-CT prior to treatment
- At least 3 months life expectation
- Informed consented
- No previous use of study drug
Exclusion Criteria:
- Has accepted Chemotherapy before
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
- Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
- HIV infection
- If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
- Other uncontrollable medical condition that may that may interfere the participation of the study
Sites / Locations
- Ruijin hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iR2
Arm Description
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
Outcomes
Primary Outcome Measures
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Secondary Outcome Measures
Overall response rate
Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Overall survival
Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949062
Brief Title
Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
Official Title
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin 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
This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。
Detailed Description
This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
iR2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iR2
Arm Type
Experimental
Arm Description
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Relvimid
Intervention Description
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
Primary Outcome Measure Information:
Title
Complete response rate
Description
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Title
Progression free survival
Description
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Overall survival
Description
Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Other Pre-specified Outcome Measures:
Title
Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
Description
cfDNA in peripheral blood assessed by local lab
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed diffuse large B cell lymphoma, treatment naive
Age > 75 years
Ineligible for standard chemotherapy
Must has measurable lesion in CT or PET-CT prior to treatment
At least 3 months life expectation
Informed consented
No previous use of study drug
Exclusion Criteria:
Has accepted Chemotherapy before
Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
HIV infection
If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Other uncontrollable medical condition that may that may interfere the participation of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36102758
Citation
Xu PP, Shi ZY, Qian Y, Cheng S, Zhu Y, Jiang L, Li JF, Fang H, Huang HY, Yi HM, Ouyang BS, Wang L, Zhao WL. Ibrutinib, rituximab, and lenalidomide in unfit or frail patients aged 75 years or older with de novo diffuse large B-cell lymphoma: a phase 2, single-arm study. Lancet Healthy Longev. 2022 Jul;3(7):e481-e490. doi: 10.1016/S2666-7568(22)00123-4.
Results Reference
derived
Learn more about this trial
Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
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