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
Enrolling By Invitation
99 years and younger
All
Phase
N/A
1 Location
Brief description of study
The purpose of this Treatment Plan is to allow access to tisagenlecleucel (CTL019) for eligible patients diagnosed with acute lymphoblastic leukemia (ALL) or large b-cell lymphomas who are unable to receive commercially manufactured product due to failure of the incoming apheresis material or outgoing product to meet the commercial specifications and where no
overwhelming safety concerns has been identified for manufacture and release of the out of specification product.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: acute lymphoblastic leukemia
-
Age: - 99 Years
-
Gender: All
Updated on
11 Sep 2024.
Study ID: 831527
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