GA NCORP

NCORP Trials

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

Status
Completed
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 - 75 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03575351
Protocol IDs
JCAR017-BCM-003 (primary)
NCI-2018-02503
2018-000929-32
U1111-1213-1944
Study Sponsor
Celgene

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.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD