Clinical Trials /

CTL019 Out of Specification MAP for ALL or DLBCL Patients

NCT03601442

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Available

Trial Eligibility

Document

Title

  • Brief Title: CTL019 Out of Specification MAP for ALL or DLBCL Patients
  • Official Title: Managed Access Program (MAP) to Provide Access to CTL019, for ALL or DLBCL Patients With Out of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification for Commercial Release

Clinical Trial IDs

  • ORG STUDY ID: CCTL019B2003I
  • NCT ID: NCT03601442

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

DrugSynonymsArms
CTL019tisagenlecleucel, Kymriah

Purpose

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.

Detailed Description

      The purpose of this Managed Access Program (MAP) Treatment Plan is 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 where no overwhelming safety concerns has been
      identified for manufacture and release of the out of specification product.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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.

          -  Not excluded from commercial manufacturing under the prescribing guidelines for their
             country

          -  Out of specification material has not been deemed to pose an undue safety risk to the
             patient

          -  Is suffering from a serious or life-threatening disease or condition

          -  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:

          -  Product can be commercially manufactured per the specification of the country in which
             treatment will occur.

          -  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
      
Maximum Eligible Age:25 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Details

Phase:
Primary Purpose:Expanded Access
Overall Status:Available
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Acute Lymphoblastic Leukemia
  • ALL
  • Pediatric
  • Diffuse Large b-cell Lymphoma
  • DLBCL
  • Adult
  • Relapse
  • Refractory
  • CTL019
  • tisagenlecleucel
  • Kymriah
  • CART19
  • CART
  • CAR T cells
  • Chimeric antigen receptor
  • Manufacturing
  • Expanded Access
  • Out of Specification

Last Updated

October 23, 2020