Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Vose, Julie
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03570892?cond=NCT03570892&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures:
(1) Event-free survival (EFS) [ Time Frame: 5 years ]
Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.
Secondary Outcome Measures:
(1) EFS as assessed by local investigator [ Time Frame: 5 years ]
EFS as assessed by local investigator
(2) Overall Survival (OS) [ Time Frame: 5 years ]
Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause
(3) Overall Response Rate (ORR) [ Time Frame: 5 years ]
Overall Response Rate (ORR) as per the Lugano criteria as per BIRC review and local investigator assessment
(4) Duration of Response (DOR) [ Time Frame: 5 years ]
Duration of response: time from the date of first documented response of CR or PR to the date of first documented progression (SD or PD at or after the week 12 assessment will be considered progression) or death due to aggressive B-cell NHL. DOR will be summarized by BIRC and local response
(5) SF-36v2 [ Time Frame: 5 years ]
Time to definitive deterioration in SF-36v2
(6) FACT-Lym [ Time Frame: 5 years ]
Time to definitive deterioration in FACT-Lym
(7) EQ-VAS [ Time Frame: 5 years ]
Time to definitive deterioration in EQ-VAS
(8) Tisagenlecleucel transgene concentrations [ Time Frame: 5 years ]
qPCR will be used to measure tisagenlecleucel transgene concentrations in peripheral blood and bone marrow
(9) Tisagenlecleucel immunogenicity (humoral and cellular) [ Time Frame: 5 years ]
Pre-existing and treatment related immunogenicity (humoral and cellular) of tisagenlecleucel will be characterized.
(10) Presence of replication competent lentivirus (RCL) [ Time Frame: 5 years ]
The presence of RCL will be assessed by VSV-qPCR in patients receiving tisagenlecleucel