Clinical trial NCT05338892: Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Official title: Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)
Non-Hodgkin lymphoma
Chronic lymphocytic leukemia
Follicular lymphoma
Odronextamab
ORCHID
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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:

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)


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 84 months
Secondary outcomes:
measure: Complete Response (CR) rate
timeFrame: Up to 84 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 84 months
measure: Overall Survival (OS)
timeFrame: Up to 84 months
measure: Duration of Response (DOR)
timeFrame: Up to 84 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 84 months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 84 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Regeneron Research Facility
city: Caen
country: France
facility: Regeneron Research Facility
city: Paris
country: France
facility: Regeneron Research Facility
city: Pierre-Benite
country: France
facility: Regeneron Research Facility
city: Essen
country: Germany
facility: Regeneron Research Facility
city: Frankfurt
country: Germany
facility: Regeneron Research Facility
city: London
country: United Kingdom
facility: Regeneron Research Facility
city: Manchester
country: United Kingdom
facility: Regeneron Research Facility
city: Nottingham
country: United Kingdom
facility: Regeneron Research Facility
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: