NCT05338892

Brief Summary

Primary Objective: To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:

  • Independent central review, and
  • Treating physician evaluation
  • Progression Free Survival (PFS) according to Lugano classification and as assessed by:
  • Independent central review, and
  • Treating physician evaluation
  • Overall Survival (OS)
  • Duration of response (DOR) according to Lugano classification and as assessed by
  • Independent central review and
  • Treating physician evaluation
  • Disease control rate (DCR) according to Lugano classification and as assessed by:
  • Independent central reviewed
  • Treating physician evaluation
  • Time to next treatment (TTNT)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
595

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
4 countries

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 22, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 14, 2022

Last Update Submit

October 18, 2023

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)Non-Hodgkin lymphomaChronic lymphocytic leukemiaFollicular lymphomaOdronextamabORCHID

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    The proportion of best overall response of complete response (CR) or partial response (PR).

    Up to 84 months

Secondary Outcomes (6)

  • Complete Response (CR) rate

    Up to 84 months

  • Progression Free Survival (PFS)

    Up to 84 months

  • Overall Survival (OS)

    Up to 84 months

  • Duration of Response (DOR)

    Up to 84 months

  • Disease Control Rate (DCR)

    Up to 84 months

  • +1 more secondary outcomes

Study Arms (1)

Cohort 1

Participants with r/r DLBCL who were treated with at least 2 prior systemic therapies in the real-world setting

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

No study treatment will be administered on this study.

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult participants with DLBCL who have relapsed after or are refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

You may qualify if:

  • Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol
  • Have been r/r to at least 2 lines of systemic therapy for DLBCL, including an anti-CD20 antibody and an alkylating agent as defined in the protocol

You may not qualify if:

  • Have measurable disease on cross sectional imaging (defined as at least 1 bi-dimensionally measurable nodal lesion ≥1.5 centimeter \[cm\] in the greatest transverse diameter \[GTD\] regardless of the short axis diameter) documented by diagnostic imaging (computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) recorded on or during the 8 weeks prior to index date
  • Have been seen at a site that routinely assesses DLBCL treatment response according to Lugano classification of malignant lymphoma (ie, sites with ≥50% DLBCL patients with treatment response according to Lugano classification)
  • Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment
  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
  • History of allo-stem cell transplant (SCT) prior to index date
  • Treatment with any chimeric antigen receptor T (CAR-T) therapy prior to index date
  • Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
  • History of neurodegenerative condition or CNS movement disorder on or prior to index date
  • Evidence of significant cardiovascular disease on or prior to index date
  • Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date
  • Eastern Cooperative Oncology Group (ECOG) performance status \>1 on or prior to index date
  • Inadequate organ function as defined in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Regeneron Research Facility

Graz, 38 8036, Austria

Location

Regeneron Research Facility

Caen, 14033, France

Location

Regeneron Research Facility

Paris, 75010, France

Location

Regeneron Research Facility

Pierre-Bénite, 69310, France

Location

Regeneron Research Facility

Essen, 45147, Germany

Location

Regeneron Research Facility

Frankfurt, 60590, Germany

Location

Regeneron Research Facility

London, EC1A 7BE, United Kingdom

Location

Regeneron Research Facility

Manchester, M20 4BX, United Kingdom

Location

Regeneron Research Facility

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseRecurrenceLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic Disease

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

June 22, 2022

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)GB(3)FR(3)AU(1)