Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (ORCHID)

Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)

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:

1. ORR according to Lugano classification and as assessed by treating physician evaluation

2. Complete Response (CR) rate according to Lugano classification and as assessed by:

   • Independent central review, and
   • Treating physician evaluation

3. Progression Free Survival (PFS) according to Lugano classification and as assessed by:

   • Independent central review, and
   • Treating physician evaluation
4. Overall Survival (OS)

5. Duration of response (DOR) according to Lugano classification and as assessed by

   • Independent central review and
   • Treating physician evaluation

6. Disease control rate (DCR) according to Lugano classification and as assessed by:

   • Independent central reviewed
   • Treating physician evaluation
7. Time to next treatment (TTNT)

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 595

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 38 8036
    • Regeneron Research Facility
• France
  • Caen, France, 14033
    • Regeneron Research Facility
  • Paris, France, 75010
    • Regeneron Research Facility
  • Pierre-Benite, France, 69310
    • Regeneron Research Facility
• Germany
  • Essen, Germany, 45147
    • Regeneron Research Facility
  • Frankfurt, Germany, 60590
    • Regeneron Research Facility
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Regeneron Research Facility
  • Manchester, United Kingdom, M20 4BX
    • Regeneron Research Facility
  • Nottingham, United Kingdom, NG5 1PB
    • Regeneron Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

Key Inclusion Criteria:

1. Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol
2. 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
3. Have initiated at least one additional line (3L+) of systemic therapy (salvage therapy) for DLBCL between 01 Jan 2015 and 30 Jun 2021 (indexing period) after meeting the criteria for r/r DLBCL as described above; the first additional line of systemic therapy during the indexing period that meets all of the remaining inclusion and exclusion criteria defined below will be the patients' first qualifying salvage therapy.
4. 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
5. 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)
6. Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
2. History of allo-stem cell transplant (SCT) prior to index date
3. Treatment with any chimeric antigen receptor T (CAR-T) therapy prior to index date
4. Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
5. History of neurodegenerative condition or CNS movement disorder on or prior to index date
6. Evidence of significant cardiovascular disease on or prior to index date
7. Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date
8. Eastern Cooperative Oncology Group (ECOG) performance status >1 on or prior to index date
9. Inadequate organ function as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No study treatment will be administered on this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The proportion of best overall response of complete response (CR) or partial response (PR).	Up to 84 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) rate	The proportion of patients with a CR after initiation of the selected line of therapy (LoT).	Up to 84 months
Progression Free Survival (PFS)	The time from the start date of the selected LoT until the first date of progressive disease (PD) or death due to any cause, whichever occurs first.	Up to 84 months
Overall Survival (OS)	The time from the start date of the selected LoT until death due to any cause.	Up to 84 months
Duration of Response (DOR)	The time from the date of the first documented CR or PR until the first date of PD or death due to any cause, whichever occurs first.	Up to 84 months
Disease Control Rate (DCR)	The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD).	Up to 84 months
Time to Next Treatment (TTNT)	The time from the start date of the selected LoT to the start of a new antineoplastic treatment line.	Up to 84 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Follicular lymphoma; Chronic lymphocytic leukemia; Non-Hodgkin lymphoma; Odronextamab; Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL); ORCHID
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: R1979-ONC-2090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No