Brief Summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel
Brief Title
Managed Access Programs for CTL019, Tisagenlecleucel
Detailed Description
CCTL019B2003I - Available - Managed Access Program (MAP) to provide access to patients with out-of-specification (OOS) leukapheresis product and/or OOS manufactured CTL019
CCTL019B2004I - Available - Managed Access Program (MAP) to provide access to reinfusion for approved indications
CCTL019A02001I - Available - Managed Access Program (MAP) to provide access to CLT019 in off-label indications
CCTL019B2004I - Available - Managed Access Program (MAP) to provide access to reinfusion for approved indications
CCTL019A02001I - Available - Managed Access Program (MAP) to provide access to CLT019 in off-label indications
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-888-669-6682
Central Contact Email
novartis.email@novartis.com
Central Contact Role
Contact
Central Contact Phone
+41613241111
Conditions
Lymphoma
Leukemia
Off-label Indications
Eligibility Criteria
Inclusion Criteria:
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.
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.
Inclusion Criteria
Inclusion Criteria:
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.
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.
Gender
All
Gender Based
false
Keywords
MAP
Expanded Access
Lymphoma
Leukemia
Off-label indications
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
0 Days
NCT Id
NCT03601442
Org Class
Industry
Org Full Name
Novartis
Org Study Id
CCTL019B2003I
Overall Status
Available
Official Title
Managed Access Programs for CTL019, Tisagenlecleucel
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ellen Fraint
Investigator Email
ellen.fraint@einsteinmed.org
Investigator Phone
Categories Mesh Debug
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- NEOPLASMS
Immune System --- IMMUNE SYSTEM DISEASES
Blood Disorders --- HEMATOLOGIC DISEASES
MeSH Terms
LYMPHOMA
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
HEMATOLOGIC DISEASES
TISAGENLECLEUCEL