CTL019 Out of Specification MAP for ALL or DLBCL Patients


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Trial ID: NCT03601442


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.

Official Title

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®)

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following

   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.


biological: CTL019


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Juliana Craig

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