IRB #

STUDY00020018

Title

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy.

Principal Investigator

Bill Chang

Study Purpose

The purpose of this study is to evaluate the effectiveness of tisagenlecleucel (CTL019) therapy in participants with B-cell lymphoblastic leukemia (B-ALL).

This study will measure the 5-year disease-free survival (DFS) in participants with high-risk B-ALL who have completed initial treatment and go on to receive tisagenlecleucel.

Medical Condition(s)

B-Cell Acute Lymphoblastic Leukemia
ALL
CTL019
tisagenlecleucel
Kymriah
Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC)

Eligibility Criteria

Inclusion Criteria:
- B-cell Acute Lymphoblastic Leukemia that expresses a protein called CD19

- Age 1 to 25 years at the time of screening

- Have received initial treatment and have minimal residual disease after that treatment

- Adequate organ function during the screening period as determined by lab blood tests

- Adequate lung and heart function

Exclusion criteria:
- Philadelphia chromosome positive ALL

- Active central nervous system (CNS) involvement of leukemia

- Treatment with any prior gene or engineered T cell therapy

Age Range

1 - 25

Healthy Volunteers Needed

No

Duration of Participation

Duration of participation on this study is up to 8 years; however, everyone who joins this study will be asked to also join a long term follow-up study to collect information for up to 15 years.

Minors Included

Yes

Contact

e-mail: trials@ohsu.edu

Phone: 503-494-1080

Sponsor

Novartis

Recruitment End

05/31/2023

Compensation Provided

No


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