Managed Access Programs for CTL019, Tisagenlecleucel

NCT03601442 | Unknown

• 1 other identifier: CCTL019B2003I
• Study Type: expanded_access
• Target: N/A
• Locations: 3 countries
• Sites: 147

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel

Conditions

Lymphoma; Leukemia; Off-label Indications

Keywords

MAP; Expanded Access; Lymphoma; Leukemia; Off-label indications

Interventions

CTL019 BIOLOGICAL

CTL019

Also known as: tisagenlecleucel

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
• The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
• There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
• The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
• Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
• Managed Access provision is allowed per local laws/regulations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Lymphoma; Leukemia

Interventions

tisagenlecleucel

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

AU (1); CA (2); US (144)