Ignite Creation Date:
2024-05-06 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03575351
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2018-06-14
Brief Title:
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk Second-line Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas TRANSFORM
Status:
COMPLETED
Status Verified Date:
2023-11
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:
TRANSFORM
Brief Summary:
The study will be conducted in compliance with the International Council for Harmonisation ICH of Technical Requirements for Registration of Pharmaceuticals for Human UseGood Clinical Practice GCP and applicable regulatory requirements
This is a randomized open-label parallel-group multi-center trial in adult subjects with Relapsed or refractory RR aggressive Non-Hodgkin lymphoma NHL to compare safety and efficacy between the standard of care SOC strategy versus JCAR017 also known as lisocabtagene maraleucel or liso-cel Subjects will be randomized to either receive SOC Arm A or to receive JCAR017 Arm B
All subjects randomized to Arm A will receive Standard of care SOC salvage therapy R-DHAP RICE or R-GDP as per physicians choice before proceeding to High dose chemotherapy HDCT and Hematopoietic stem cell transplant HSCT
Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event
Subjects randomized to Arm B will receive Lymphodepleting LD chemotherapy followed by JCAR017 infusion
This is a randomized open-label parallel-group multi-center trial in adult subjects with Relapsed or refractory RR aggressive Non-Hodgkin lymphoma NHL to compare safety and efficacy between the standard of care SOC strategy versus JCAR017 also known as lisocabtagene maraleucel or liso-cel Subjects will be randomized to either receive SOC Arm A or to receive JCAR017 Arm B
All subjects randomized to Arm A will receive Standard of care SOC salvage therapy R-DHAP RICE or R-GDP as per physicians choice before proceeding to High dose chemotherapy HDCT and Hematopoietic stem cell transplant HSCT
Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event
Subjects randomized to Arm B will receive Lymphodepleting LD chemotherapy followed by JCAR017 infusion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000929-32 | EUDRACT_NUMBER | WHO | None |
| U1111-1213-1944 | REGISTRY | None | None |