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- CCTL019B2003I: 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®)
Clinical Trial
CCTL019B2003I: 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®)
The purpose of this Managed Access Program (MAP), is to provide expanded access treatment with tisagenlecleucel (CTL019) for eligible patients who are not eligible or able to enroll in a clinical trial and do not meet the requirements for standard treatment with CTL019. As an expanded access protocol, it will provide another treatment option for these patients.
- Lymphatic System
- Adults
- Expanded Access
- Follicular Lymphoma
- Hematologic Malignancies- B-cell Acute Lymphoblastic Leukemia (ALL)
- Large B-cell Lymphoma
Eligibility Criteria
- Brief inclusion criteria: 1--Patient is not eligible or able to enroll in a clinical trial; 2--Patients must be prescribed tisagenlecleucel in line with the locally approved indications that may include B-cell ALL, large B-cell lymphoma, or follicular lymphoma that is not responding to prior treatment 3--Does not meet the standard prescribing criteria for CTL019; 4--Patient has no other treatment options. 5--Incoming apheresis material and/or final manufactured product is out of specification due to failure to meet acceptance or release specifications. Brief exclusion criteria: 1--Contraindications as per the approved local label or the IB.
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