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.
Available
| Drug | Synonyms | Arms |
|---|---|---|
| CTL019 | tisagenlecleucel, Kymriah |
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.
| Name | Type | Description | Interventions |
|---|
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 |
| Phase: | |
| Primary Purpose: | Expanded Access |
| Overall Status: | Available |
| Lead Sponsor: | Novartis Pharmaceuticals |
June 24, 2021
