BIANCA : A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

<25Age Under 25

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Diffuse Large Cell Lymphoma,Follicular Lymphoma,Lymphoma

Trial Overview Read MoreRead more

This phase II trial is evaluating the safety and effectiveness of an immunotherapy treatment in patients with B-Cell Non-Hodgkin Lymphoma that has gotten worse or not responded to prior treatment.
 

This trial is treating patients with B-Cell Non-Hodgkin Lymphoma, including the following subtypes: burkitt lymphoma/leukemia (BL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), gray zone lymphoma (GZL) and follicular lymphoma (FL).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)

Commercial Sponsor

Novartis Pharmaceuticals

Summary

Eligible patients will be enrolled and are allowed to start lymphodepleting chemotherapy as recommended in protocol, after which they will receive a single intravenous infusion of tisagenlecleucel. The efficacy of tisagenlecleucel will be evaluated via Overall Response Rate (ORR) which includes complete response (CR) and partial response (PR) as determined by local assessment. Safety assessments will be conducted until study completion.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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