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NCT03575351 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT03575351 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 184 participants.
The verdict
NCT03575351, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study Summary
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good 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 (R/R) 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 physician's 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.
Interventions
- DRUG Standard of Care
- GENETIC JCAR017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2023-10-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03575351
The ClinicalTrials.gov registry entry for NCT03575351 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03575351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03575351 about?
NCT03575351 is a clinical study titled "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". The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-c...
What is the current status of trial NCT03575351?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2018-10-23. Estimated completion is 2023-10-23.
What interventions are being tested in trial NCT03575351?
The interventions under investigation include: Standard of Care (DRUG), JCAR017 (GENETIC).
Who is sponsoring clinical trial NCT03575351?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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