A Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL) (BIANCA)

Phase 2

Completed

• Conditions: Burkitt Leukemie; lymphoma; Mature non-Hodgkin Lymphoma; 10025320

• Registration Number: NL-OMON49158
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

* Males or females 1 up to 25 years of age at the time of screening.
* Mature B-cell non-Hodgkin lymphoma and Burkitt leukemia, see protocol
paragraph 5.1 item 2 for details.
* Relapse after one or more prior therapies or primary refractory, see
protocol paragraph 5.1 item 3 for details.
* Measurable disease, see protocol Appendix 1 for details.
* Lansky (age < 16 years) or Karnofsky (age * 16 years) performance status *
60%.
* Adequate organ function. See protocol paragraph 5.1 item 7-8 for details

Exclusion Criteria

* Any prior anti-CD19 therapy.
* Any prior gene or engineered T cell therapy.
* Allogeneic hematopoietic stem cell transplant (HSCT) <3 months prior to
screening and *4 months prior to infusion.
* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease
in patients who received prior allogenic HSCT.
* Active or prior hepatitis B or C (positive test), positive HIV test. See
protocol paragraph 5.2 item 7-8 for details.
* Active neurological autoimmune or inflammatory disorders.
* Active CNS involvement by malignancy.
* Pregnant or lactating women, females of childbearing potential and males not
using adequate contraception. See protocol paragraph 5.2 item 16-18 for
details.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall response rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Duration of response, event free survival, relapse free survival, overall<br /><br>survival, adverse events, kinetics, immunogenicity, transplant, cytokine<br /><br>release syndrome.</p><br>