Status:
COMPLETED
Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Lead Sponsor:
Juno Therapeutics, a Subsidiary of Celgene
Conditions:
Lymphoma, Non-Hodgkin
Lymphoma, Nonhodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single lin...
Eligibility Criteria
Inclusion
- Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma \[DHL/THL\]), and follicular lymphoma Grade 3B per WHO 2016 classification
- Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
- Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
- Positron emission tomography (PET)-positive disease
- Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
- ECOG performance status of 0, or 1, or 2
- Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
- Subjects must agree to use appropriate contraception
- Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy
Exclusion
- Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
- History of another primary malignancy that has not been in remission for at least 2 years.
- Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
- Active hepatitis B or hepatitis C infection at the time of screening
- History of or active human immunodeficiency virus (HIV) infection at the time of screening
- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
- History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
- History or presence of clinically relevant CNS pathology
- Pregnant or nursing women
- Subject does not meet protocol-specified washout periods for prior treatments
- Prior hematopoietic stem cell transplant
- Progressive vascular tumor invasion, thrombosis, or embolism
- Venous thrombosis or embolism not managed on stable regimen of anticoagulation
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions
Key Trial Info
Start Date :
July 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03483103
Start Date
July 27 2018
End Date
December 1 2022
Last Update
December 20 2023
Active Locations (59)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Local Institution - 0043
Gilbert, Arizona, United States, 85234
3
Scripps Clinic
La Jolla, California, United States, 92037
4
UNC School of Medicine
Los Angeles, California, United States, 90095