Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
NCT ID: NCT03949062
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2019-03-13
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
Ibrutinib
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
Lenalidomide
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
Rituximab
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
Interventions
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Ibrutinib
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
Lenalidomide
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
Rituximab
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director，Hematology Department
Principal Investigators
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Weili Zhao, PhD
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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Ruijin hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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NHL-iR2
Identifier Type: -
Identifier Source: org_study_id
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