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CAR T-cell Therapy

Tisagenlecleucel for Non-Hodgkin's Lymphoma (BIANCA Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 years
Awards & highlights

BIANCA Trial Summary

This trial is testing a new treatment for children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma. The new treatment is tisagenlecleucel, and the trial is testing its efficacy and safety.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

BIANCA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) as Determined by Local Investigator
Secondary outcome measures
Cellular Kinetics Parameter: AUC0-28d
Cellular Kinetics Parameter: Clast
Cellular Kinetics Parameter: Cmax
+10 more

BIANCA Trial Design

1Treatment groups
Experimental Treatment
Group I: TisagenlecleucelExperimental Treatment3 Interventions
Participants were infused once with CAR-positive viable T cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
2019
Completed Phase 2
~360
lymphodepleting chemotherapy
2019
Completed Phase 2
~40
Bridging Therapy
2019
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients will be given this medication to test its effects?

"This particular research study is no longer looking for new participants. The listing was created on February 15th, 2019 and updated for the last time on October 31st, 2022. If you are interested in other lymphoma studies, there are currently 1820 ongoing trials related to diffuse lymphoma and 18 clinical trials testing lymphodepleting chemotherapy that are actively recruiting patients."

Answered by AI

Does this type of chemotherapy have a long history?

"Lymphodepleting chemotherapy was first studied in the year 2015 at Oregon Health & Science University Doernbecher Children's Hosp.. Since then, there have been 12 completed clinical trials. Currently, 18 studies are actively recruiting patients. A large portion of these active studies are based out of New york City."

Answered by AI

Are there any current vacancies for patients in this research?

"This trial is now closed to new participants. The study was posted on February 15th, 2019 and received its last update on October 31st, 2022. However, there are currently 1820 clinical trials related to lymphoma that are actively admitting patients."

Answered by AI

What is the legal status of lymphodepleting chemotherapy?

"Lymphodepleting chemotherapy is estimated to be a 2 in terms of safety. This rating comes from the fact that, while there have been Phase 2 trials testing its safety, none have looked at whether it is effective."

Answered by AI

What other types of research does this study compare to?

"Novartis Pharmaceuticals sponsored the first study on lymphodepleting chemotherapy in 2015, which involved 97 patients. After this initial research was published, Phase 2 drug approval was granted in [year]. As of today, there are 18 active clinical trials being conducted in 115 cities and 22 countries."

Answered by AI
~6 spots leftby Apr 2025