CTL019 Out of Specification MAP for ALL or DLBCL Patients

Study Overview
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Brief Summary
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Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

Detailed Description
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The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Official Title
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Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)

Conditions
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Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL)

Intervention / Treatment
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* Biological: CTL019


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria: Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP). - Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label. Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). These may include: pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL) adult patients with r/r diffuse large B-cell lymphoma (DLBCL) Informed consent must be obtained prior to treatment The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications Exclusion Criteria: Patients eligible for this Treatment Plan must not meet any of the following criteria: 1. Contraindications as per the approved local label or the IB.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CTL019|CTL019|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, ALL, Pediatric, Diffuse Large b-cell Lymphoma, DLBCL, Adult, Relapse, Refractory, CTL019, tisagenlecleucel, Kymriah, CART19, CART, CAR T cells, Chimeric antigen receptor, Manufacturing, Expanded Access, Out of Specification