Trials / Available
AvailableNCT03601442
CTL019 Out of Specification MAP for ALL or DLBCL Patients
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®)
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Day – 25 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CTL019 | CTL019 |
Timeline
- First posted
- 2018-07-26
- Last updated
- 2025-12-05
Locations
147 sites across 3 countries: United States, Australia, Canada
Source: ClinicalTrials.gov record NCT03601442. Inclusion in this directory is not an endorsement.