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
Public ClinicalTrials.gov record NCT03575351. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03575351
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 22, 2018
- Primary completion
- Oct 22, 2023
- Completion
- Oct 22, 2023
- Last update posted
- Aug 2, 2025
2018 – 2023
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 129 | Scottsdale | Arizona | 85258 | — |
| Local Institution - 116 | Scottsdale | Arizona | 85259 | — |
| Local Institution - 115 | San Francisco | California | 94143 | — |
| Local Institution - 106 | Aurora | Colorado | 80045 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Local Institution - 126 | Tampa | Florida | 33612 | — |
| Local Institution - 108 | Atlanta | Georgia | 30322 | — |
| Local Institution - 107 | Atlanta | Georgia | 30342 | — |
| Local Institution - 122 | Chicago | Illinois | 60611 | — |
| Loyola University Medical Center Cardinal Bernardin Cancer Center | Maywood | Illinois | 60153 | — |
| Local Institution - 102 | Boston | Massachusetts | 02114 | — |
| Local Institution - 104 | Boston | Massachusetts | 02215 | — |
| Local Institution - 120 | Ann Arbor | Michigan | 48109 | — |
| Local Institution - 119 | Detroit | Michigan | 48201 | — |
| Local Institution - 112 | Minneapolis | Minnesota | 55455 | — |
| Local Institution - 103 | Rochester | Minnesota | 55905-0001 | — |
| Local Institution - 100 | Omaha | Nebraska | 68198 | — |
| Local Institution - 121 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 111 | Buffalo | New York | 14263 | — |
| Local Institution - 117 | New York | New York | 10065 | — |
| Local Institution - 125 | Charlotte | North Carolina | 28204 | — |
| Local Institution - 127 | Oklahoma City | Oklahoma | 73104 | — |
| Local Institution - 101 | Portland | Oregon | 97239 | — |
| Local Institution - 123 | Pittsburgh | Pennsylvania | 15232 | — |
| Local Institution - 109 | Dallas | Texas | 75246 | — |
| Local Institution - 124 | Houston | Texas | 77030 | — |
| Local Institution - 114 | Richmond | Virginia | 23298 | — |
| Local Institution - 110 | Seattle | Washington | 98109-4417 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03575351, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2025 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03575351 live on ClinicalTrials.gov.