Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (NCT03570892) | Clinical Trial Compass
CompletedPhase 3
Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
United States330 participantsStarted 2019-05-07
Plain-language summary
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016):
* DLBCL, NOS,
* FL grade 3B,
* Primary mediastinal large B cell lymphoma (PMBCL),
* T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL),
* DLBCL associated with chronic inflammation,
* Intravascular large B-cell lymphoma,
* ALK+ large B-cell lymphoma,
* B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkin's Lymphoma (HL)),
* High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,
* High-grade B-cell lymphoma, NOS
* HHV8+ DLBCL, NOS
* DLBCL transforming from follicular lymphoma
* DLBCL transforming from marginal zone lymphoma
* DLBCL, leg type
* Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR).
* Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry
* Disease that is both active on PET scan (defined as 5-Deauville scorepoint-scale of 4 or 5) and measurable on CT scan, defined as::
* Nodal lesions \>15 mm in the long axis, regardless of the length of the short axis, and/or
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What they're measuring
1
Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment