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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.