NCT05338892CompletedNot Applicable
Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)
Regeneron Pharmaceuticals1 site in 1 country595 target enrollmentStarted: June 22, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 595
- Locations
- 1
- Primary Endpoint
- Objective response rate
Study Overview
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:
- ORR according to Lugano classification and as assessed by treating physician evaluation
- Complete Response (CR) rate according to Lugano classification and as assessed by:
- 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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
- •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
Exclusion Criteria
- •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
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
Outcomes
Primary Outcomes
Objective response rate
Time Frame: Up to 84 months
The proportion of best overall response of complete response (CR) or partial response (PR).
Secondary Outcomes
- Time to Next Treatment (TTNT)(Up to 84 months)
- Complete Response (CR) rate(Up to 84 months)
- Progression Free Survival (PFS)(Up to 84 months)
- Disease Control Rate (DCR)(Up to 84 months)
- Overall Survival (OS)(Up to 84 months)
- Duration of Response (DOR)(Up to 84 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's DiseaseHodgkin's DiseaseNCT00284804Bristol-Myers Squibb74
Completed
Not Applicable
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular LymphomaRelapsed/Refractory Follicular LymphomaNCT05338879Regeneron Pharmaceuticals247
Completed
Phase 2
KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)Adult T-cell Leukemia-LymphomaNCT01626664Kyowa Kirin, Inc.71
Terminated
Phase 2
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Lymphoma, Mantle-CellNCT02455297Bayer4
Not yet recruiting
Not Applicable
Recurrence in Patients With Differentiated Thyroid CancerDifferentiated Thyroid CancerNCT06154863Assiut University100