NCT03949062

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。

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

May 10, 2019

Last Update Submit

February 15, 2021

Conditions

Diffuse Large B Cell Lymphoma

Keywords

iR2

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    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 Outcomes (4)

  • Overall response rate

    At the end of Cycle 6 (each cycle is 21 days)

  • Progression free survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Overall survival

    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

    Baseline up to data cut-off (up to approximately 4 years)

Other Outcomes (1)

  • Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

    Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

iR2

EXPERIMENTAL

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

Drug: IbrutinibDrug: LenalidomideDrug: Rituximab

Interventions

IbrutinibDRUG

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

Also known as: Imbruvica
iR2
LenalidomideDRUG

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

Also known as: Relvimid
iR2
RituximabDRUG

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

Also known as: Rituxan
iR2

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Has accepted Chemotherapy before
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • 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.

    PMID: 36102758DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ibrutinibLenalidomideRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Weili Zhao, PhD

    Ruijin Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director，Hematology Department

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

March 13, 2019

Primary Completion

March 1, 2021

Study Completion

May 1, 2022

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

CN(1)