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Clinical Trial 19724

Cancer Type: Malignant Hematology
Interventions:

Study Type: Treatment
Phase of Study: N/A
Investigators:

  • Frederick Locke

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

Objective

Novartis will manufacture these cells despite being out of specification. This is called Individual patient Request

Inclusion Criteria

  • Written informed consent must be obtained prior to any screening procedures or treatment assignment.
  • Has a patient specific batch of CTL019 which is out of specification either due to out of specification incoming apheresis or final product not meeting commercial release.
  • Repeat leukapheresis is not feasible per the treating physician assessment
  • Does not have access to a comparable or satisfactory alternative treatment
  • Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options, the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient
  • Meets any other relevant medical criteria for compassionate use of the investigational product
  • Is not being transferred from an ongoing clinical trial for which they are still eligible

  • Exclusion Criteria

  • Patients who are able to repeat leukapheresis.
  • Evidence of CD19 negative disease
  • HIV positive patients
  • Patients with active replication of Hep B or active or latent Hep C
  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
  • Uncontrolled active infection or inflammation
  • History of unstable angina or MI within 6 months prior to screening
  • Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment