ASH Clinical News ACN_5.4_Full Issue_web | Page 15
NOW ENROLLING
R/R DLBCL PATIENTS FOR THE
2L ZUMA-7 CAR T-CELL STUDY
ZUMA-7 is a global, phase 3, randomized study evaluating the effi cacy of axicabtagene ciloleucel versus
standard-of-care therapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
Study Design
Primary Endpoint
Event-free survival ‡
Secondary Endpoints
Objective response rate
Overall survival
Progression-free survival
Duration of response
Patient-reported outcomes
Safety
Key Eligibility Criteria
• Patients ≥18 years old with histologically proven DLBCL (including transformation from FL)
• Adequate 1L therapy
• Relapsed/refractory after 1L chemoimmunotherapy
— Refractory disease defi ned as no CR to 1L therapy
— Relapsed disease defi ned as CR to 1L therapy followed by biopsy-proven disease or relapse ≤12 months
after initiation of 1L therapy
• Patients who previously received CD19-targeted therapy, CAR of other genetically modifi ed T-cell
therapy, ASCT, or allogeneic SCT are ineligible to enroll
• Intent to proceed to HDT and ASCT
• ECOG performance score of 0 or 1
• Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function
Contact [email protected] for
clinical trial inquiries and view other clinical
trials at kitepharma.com/pipeline.
Visit clinicaltrials.gov for more information
on trial inclusion and exclusion criteria.
Clinicaltrials.gov: NCT03391466
The safety and effi cacy of these investigational agents and/or uses have not been established.
* Patients will receive a 3-day lymphodepleting chemotherapy regimen consisting of fl udarabine 30 mg/m 2 /d + cyclophosphamide 500 mg/m 2 /d (days -5 to -3)
followed by 2 days rest (days -2 and -1). On day 0, patients will receive a single infusion of axi-cel administered intravenously at 2 x 10 6 anti-CD19 CAR T cells/kg.
Patients will receive 2-3 cycles of investigator’s choice of a platinum-based combination chemotherapy regimen (eg, R-ICE) administered every 2-3 weeks.
‡
Event is defined as death, disease progression, or new lymphoma therapy.
†
1L=fi rst line; 2L=second line; ASCT=autologous stem cell transplant; CAR=chimeric antigen receptor; CR=complete response; DLBCL=diff use large B-cell lymphoma;
ECOG=Eastern Cooperative Oncology Group; FL=follicular lymphoma; HDT=high-dose therapy; SCT=stem cell transplant.
Reference: Oluwole OO, et al. J Clin Oncol . 2018;36(suppl). Abstract TPS7585.
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MRC-00138 10/2018
Santa Monica, CA