Non Hodgkin Lymphoma Clinical Trial

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Summary

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

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Full Description

This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting.

Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years at the time of consent
Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT.
Positron-emission tomography-positive disease by Lugano Classification
Eastern Cooperative Oncology Group performance status of 0 to 1
Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function
Adequate vascular access for leukapheresis procedure
Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
Subjects must agree to use appropriate contraception.

Exclusion Criteria:

Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
History of prior allogeneic hematopoietic stem cell transplant
Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear.
Active hepatitis B or hepatitis C infection at the time of screening
History of or active human immunodeficiency virus infection at the time of screening
Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration
Presence of acute or chronic graft-versus-host disease
History of clinically significant cardiac conditions within the past 6 months
History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Pregnant or nursing women
Subject does not meet protocol-specified washout periods for certain prior treatments
Prior CAR T-cell or other genetically modified T-cell therapy
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 that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT03744676

Recruitment Status:

Active, not recruiting

Sponsor:

Juno Therapeutics, a Subsidiary of Celgene

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There are 25 Locations for this study

See Locations Near You

Cedars-Sinai Medical Group
Los Angeles California, 90048, United States
Local Institution - 0057
Los Angeles California, 90048, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Local Institution - 0060
Denver Colorado, 80218, United States
Local Institution - 0089
Miami Florida, 33176, United States
Miami Cancer Institute at Baptist health
Miami Florida, 33176, United States
Advent Health Medical Group Blood & Marrow Transplant at Orlando
Orlando Florida, 32804, United States
Local Institution - 0081
Orlando Florida, 32804, United States
Indiana Blood and Marrow Transplantation
Indianapolis Indiana, 46237, United States
Local Institution - 0065
Indianapolis Indiana, 46237, United States
Local Institution - 0069
Wichita Kansas, 67124, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Local Institution - 0064
Louisville Kentucky, 40207, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Ascension Providence Hospital Southfield Cancer Center
Southfield Michigan, 48075, United States
Local Institution - 0101
Southfield Michigan, 48075, United States
Astera Cancer Care
East Brunswick New Jersey, 08816, United States
Local Institution - 0052
East Brunswick New Jersey, 08816, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Local Institution - 0066
Morristown New Jersey, 07962, United States
Local Institution - 0041
Albany New York, 12208, United States
USOR - New York Oncology Hematology - Albany Cancer Center
Albany New York, 12208, United States
Local Institution - 0039
Cincinnati Ohio, 45236, United States
USOR - Oncology Hematology Care - Blue Ash
Cincinnati Ohio, 45236, United States
Local Institution - 0098
Eugene Oregon, 97401, United States
Willamette Valley Cancer Institute
Eugene Oregon, 97401, United States
Local Institution - 0051
Portland Oregon, 97213, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
Local Institution - 0037
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Eastside Cancer Center
Greenville South Carolina, 29615, United States
Local Institution - 0063
Nashville Tennessee, 37203, United States
Tennessee Oncology - Nashville - Centennial
Nashville Tennessee, 37203, United States
Local Institution - 0097
Dallas Texas, 75230, United States
USOR - Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Local Institution - 0061
San Antonio Texas, 78229, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
Local Institution - 0096
Tyler Texas, 75702, United States
USOR - Texas Oncology - Tyler
Tyler Texas, 75702, United States
Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant
Salt Lake City Utah, 84143, United States
Local Institution - 0074
Salt Lake City Utah, 84143, United States
Local Institution - 0036
Norfolk Virginia, 23502, United States
USOR - Virginia Oncology Associates
Norfolk Virginia, 23502, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT03744676

Recruitment Status:

Active, not recruiting

Sponsor:


Juno Therapeutics, a Subsidiary of Celgene

How clear is this clinincal trial information?

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