Diffuse Large B Cell Lymphoma
Conditions
Keywords
iR2
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.
Interventions
DRUGIbrutinib
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
DRUGLenalidomide
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
DRUGRituximab
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed diffuse large B cell lymphoma, treatment naive 2. Age \> 75 years 3. Ineligible for standard chemotherapy 4. Must has measurable lesion in CT or PET-CT prior to treatment 5. At least 3 months life expectation 6. Informed consented 7. No previous use of study drug
Exclusion criteria
1. Has accepted Chemotherapy before 2. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease 3. 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 4. Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation 5. HIV infection 6. 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. 7. Other uncontrollable medical condition that may that may interfere the participation of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | At the end of Cycle 6 (each cycle is 21 days) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | At the end of Cycle 6 (each cycle is 21 days) | 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 | Baseline up to data cut-off (up to approximately 4 years) | 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 | Baseline up to data cut-off (up to approximately 4 years) | 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 | Baseline up to data cut-off (up to approximately 4 years) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | Baseline up to data cut-off (up to approximately 4 years) | cfDNA in peripheral blood assessed by local lab |
Countries
China
Outcome results
None listed