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CTL019 Out of Specification MAP for ALL or DLBCL Patients

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ClinicalTrials.gov Identifier: NCT03601442
Expanded Access Status : Available
First Posted : July 26, 2018
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia (ALL) Diffuse Large B-cell Lymphoma (DLBCL) Biological: CTL019

Detailed Description:
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.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: 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®)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: CTL019
    CTL019
    Other Names:
    • tisagenlecleucel
    • Kymriah
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

  1. 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.

  2. 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)
  3. Informed consent must be obtained prior to treatment
  4. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601442


Contacts
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Contact: MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03601442    
Other Study ID Numbers: CCTL019B2003I
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia
Hematologic Diseases
Lymphoma, Non-Hodgkin
Tisagenlecleucel
Antineoplastic Agents, Immunological
Antineoplastic Agents