Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 8:31 PM
Study NCT ID:
NCT05338892
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORCHID
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: