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

February 15, 2021 updated by: Zhao Weili, Ruijin Hospital

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

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。

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 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
At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 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
At the end of Cycle 6 (each cycle is 21 days)
Progression free survival
Time Frame: 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.
Baseline up to data cut-off (up to approximately 4 years)
Overall survival
Time Frame: 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.
Baseline up to data cut-off (up to approximately 4 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 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.
Baseline up to data cut-off (up to approximately 4 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
cfDNA in peripheral blood assessed by local lab
Baseline up to data cut-off (up to approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Weili Zhao, PhD, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-iR2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B Cell Lymphoma

Clinical Trials on Ibrutinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe