Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05541341
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • tisagenlecleucel — OTHER
    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

Study Details

This will be a multicenter, national, non-interventional, prospective cohort study

Key Dates

First listed
Sep 15, 2022
Start date
Nov 23, 2023
Status verified
Jun 2025
Primary completion
Nov 23, 2043
Completion
Nov 23, 2043

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Acute Lymphoblastic Leukemia (ALL)
    Children/young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who received tisagenlecleucel infusion
  • Arm: Diffuse Large B-cell Lymphoma (DLBCL)
    Adult patients with relapsed/refractory Diffuse Large B-cell Lymphoma who received tisagenlecleucel infusion
  • Arm: Follicular Lymphoma (FL)
    Patients of any gender aged 18 year or older, with relapsed/refractory Follicular Lymphoma who received tisagenlecleucel infusion.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 15 years ]

Central Contacts

Find similar trials

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials

Related Studies