Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
Enrollment Eligibility
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:
1. Patients must be treated at a healthcare facility that has been certified /qualified
by Novartis to dispense and administer tisagenlecleucel in line with the
tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States
(US) or the local Risk Management Plan (RMP).
- Note that tisagenlecleucel treatment should be initiated under the direction of and
supervised by a HCP experienced in the treatment of hematological malignancies and
trained for administration and management of patients treated with tisagenlecleucel.
The healthcare facility must have tocilizumab for use in the event of cytokine release
syndrome and emergency equipment per patient prior to infusion on site and ensure
timely access to additional doses of tocilizumab; for detailed requirements refer to
the approved local label.
2. Patients must be prescribed tisagenlecleucel in line with the locally approved
indications (for the precise indication statements see approved local product label).
These may include:
- pediatric and young adult patients up to and (including) 25 years of age with
refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
- adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
3. Informed consent must be obtained prior to treatment
4. The incoming apheresis material and/or the final manufactured product is out of
specification due to failure to meet acceptance or release specifications
Exclusion Criteria:
Patients eligible for this Treatment Plan must not meet any of the following criteria:
1. Contraindications as per the approved local label or the IB.