Non-Hodgkin Lymphoma (BIANCA)

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Non-Hodgkin Lymphoma (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 (B-Cell NHL).

Overview

This Study Is Recruiting: Phase II Actual Start Date: [February 15, 2019] Estimated Completion Date: [February 15, 2023] Novartis Reference Number: CCTL019C2202
Condition: Non-Hodgkin Lymphoma
Interventions: tisagenlecleucel Estimated Enrollment: [35 participants] ClinicalTrials.gov Identifier: NCT03610724
This Study Is Recruiting:Phase II Actual Start Date: [February 15, 2019]
Estimated Completion Date: [February 15, 2023] Novartis Reference Number: CCTL019C2202
Condition: Non-Hodgkin Lymphoma
Interventions: tisagenlecleucel
Estimated Enrollment: [35 participants] ClinicalTrials.gov Identifier: NCT03610724

Study Goal

The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are < 18 years of age (weighing at least 6 kg)
  • Have confirmed CD19+ relapsed/refractory mature B-cell NHL
    • Subtypes included: Burkitt’s lymphoma, Diffuse large B-cell lymphoma, Follicular lymphoma, Gray zone lymphoma, and Primary mediastinal B-cell lymphoma
    • Bone marrow involvement of > 25% lymphoma cells will be excluded
    • Have relapsed after 1 or more prior therapies or are primary refractory
    • Have progressed after prior allogenic and autologous hematopoietic stem cell transplant
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Definitions:
B-Cell NHL - B-Cell Non-Hodgkin Lymphoma, CD19 - Cluster of differentiation 19, r/r - relapsed/refractory , ORR - overall response rate

Last Updated: May 1, 2019

4/19 M-GON-1210817