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

Active:	No
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT03575351
Trial Phases:	Phase III	Protocol IDs:	JCAR017-BCM-003 (primary) NCI-2018-02503 2018-000929-32 U1111-1213-1944
Eligibility:	18 - 75 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Celgene
NCI Full Details:	http://clinicaltrials.gov/show/NCT03575351

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 in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
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

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