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

Phase 2

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Ibrutinib; Drug: Lenalidomide; Drug: Rituximab

• Registration Number: NCT03949062
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2019-03-13
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iR2	Ibrutinib	Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
iR2	Lenalidomide	Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
iR2	Rituximab	Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China