NCT06176729

Brief Summary

This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
18mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress65%
Oct 2023Oct 2027

Study Start

First participant enrolled

October 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2027

Expected
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 5, 2023

Last Update Submit

December 19, 2023

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • complete remission rate

    proportion of patients achieving complete remission

    evaluated every 3 months，up to 24 months

Secondary Outcomes (4)

  • overall remission rate

    evaluated every 3 months，up to 24 months

  • 2 year progression-free survival rate

    2 years after last patient included

  • 2 year overall survival rate

    2 years after last patient included

  • any adverse event occurred during this study

    2 years after last patient included

Study Arms (1)

Experimental arm

EXPERIMENTAL

Pola-R2 regimen Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days

Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide

Interventions

Polatuzumab Vedotin, Rituximab, LenalidomideDRUG

polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days

Experimental arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The patient volunteered to participate in the study and signed the Informed Consent
  • Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
  • Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
  • Adequate organ function and adequate bone marrow reserve

You may not qualify if:

  • Coexisting malignancy other than lymphoma
  • Active HBV infection
  • Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

polatuzumab vedotinRituximabLenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yan Zhang, MD

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Wei Wang, MD

CONTACT

+86 13810131294wangweipumc@163.com

Zhaohui Zhu, MD

CONTACT

+861069156874pumchkyc@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate director of department of hematology

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 20, 2023

Study Start

October 24, 2023

Primary Completion

October 24, 2025

Study Completion (Estimated)

October 24, 2027

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)