CTL019 Out of Specification MAP for ALL or DLBCL Patients

  • Expanded Access
  • Recruiting
  • NCT03601442
Eligibility Details Visit Clinicaltrials.gov

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

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.

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.

Gender
All

Age Group
Any

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03601442

IRB#IRB18-1093

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
Recruiting