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Trial Title:
Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies
NCT ID:
NCT05541341
Condition:
Diffuse Large B-cell Lymphoma
Acute Lymphoblastic Leukemia
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Tisagenlecleucel
Conditions: Keywords:
Diffuse Large B-cell Lymphoma
DLBCL
Acute Lymphoblastic Leukemia
ALL
Tisagenlecleucel
Brazil
NIS
Follicular Lymphoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
tisagenlecleucel
Description:
Prospective observational study. There is no treatment allocation. Patients prescribed
with tisagenlecleucel in the commercial setting or out-of-specification (OOS) are
eligible to enroll into this study
Arm group label:
Acute Lymphoblastic Leukemia (ALL)
Arm group label:
Diffuse Large B-cell Lymphoma (DLBCL)
Arm group label:
Follicular Lymphoma (FL)
Summary:
This will be a multicenter, national, non-interventional, prospective cohort study
Detailed description:
Eligible participants will be pediatric (<18 years) and adult patients (aged 18 years or
older) with B-cell malignancies who have received tisagenlecleucel through the commercial
setting or out-of-specification (OOS) use in Brazil. We will collect data prospectively
and complement missing information with retrospective data collection, when necessary. It
is anticipated that approximately 200 patients will be enrolled in the cohort over 5
years divided among the study indications.
Since this is a non-interventional study, no administration of study drug or application
of questionnaires will be mandated by this protocol. The study will consist of a
"Pre-infusion" and a "Post infusion follow-up period" for up to 15 years post
tisagenlecleucel infusion. All patients will be followed until death or last scheduled
visit, whichever comes first.
For the study, "pre-infusion" and "follow-up post infusion" phases are defined as:
- "Pre-infusion" will consist of the patient's information from the time of diagnosis
untiljust prior to infusion with tisagenlecleucel.
- "Follow-up Post infusion" information will comprise any information from the
infusionof tisagenlecleucel onwards.
Criteria for eligibility:
Study pop:
The study population will include pediatric/ adult patients with relapsed/refractory
B-cell acute lymphoblastic leukemia aged 0-25 years and adult patients aged ≥ 18 years
with relapsed/refractory Diffuse Large B-cell Lymphoma and relapsed/refractory follicular
lymphoma, who received tisagenlecleucel infusion in the commercial setting or
out-of-specification.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this study must meet the following criteria:
1. Patients who receive tisagenlecleucel infusion in the commercial setting or
out-of-specification (OOS) use, AND
2. Signed informed consent must be obtained prior to participation in study, AND
For ALL participants:
3. Patients of any gender aged 0-17 years (named as pediatric) with relapsed/
refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
4. Patients of any gender, aged 18-25 years (named as adults) - with relapsed/
refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
For DBLCL and FL participants:
5. Patients of any gender aged 18 years or older, who have been diagnosed with
relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel
infusion.
Exclusion Criteria:
1. Patients who did not consent to data collection.
2. Patients who received tisagenlecleucel infusion as part of any interventional
clinical trial.
Gender:
All
Minimum age:
N/A
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Minas Gerais
Zip:
34006-059
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sao Paulo
Zip:
01323-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sao Paulo
Zip:
04544-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sao Paulo
Zip:
01409-902
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Status:
Recruiting
Start date:
November 24, 2023
Completion date:
December 16, 2038
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541341
