Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

Sponsor

Ruijin Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03949062

Collaborator

(none)

Enrollment

Location

Arm

37.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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。

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: Ibrutinib Drug: Lenalidomide Drug: Rituximab	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 13, 2019

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iR2 Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).	Drug: Ibrutinib Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles Other Names: Imbruvica Drug: Lenalidomide Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles Other Names: Relvimid Drug: Rituximab Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles Other Names: Rituxan

Arm

Intervention/Treatment

Experimental: iR2

Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).

Drug: Ibrutinib

Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles

Other Names:

Imbruvica

Drug: Lenalidomide

Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles

Other Names:

Relvimid

Drug: Rituximab

Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles

Other Names:

Rituxan

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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<1.510^9/L ;Platelet<8010^9/L; ALT or AST >2ULN; AKP or bilirubin >1.5ULN ;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