Trial Search Results

CTL019 Out of Specification MAP for ALL or DLBCL Patients

The purpose of this Treatment Plan is to allow access to tisagenlecleucel (CTL019) for eligible patients diagnosed with acute lymphoblastic leukemia (ALL) or large b-cell lymphomas who are unable to receive commercially manufactured product due to failure of the incoming apheresis material or outgoing product to meet the commercial specifications and where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Biological: CTL019

Eligibility


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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Juliana Craig
650-736-0912
Recruiting