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CTL019 Out of Specification MAP for ALL or DLBCL Patients

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ClinicalTrials.gov Identifier: NCT03601442
Expanded Access Status : Available
First Posted : July 26, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia (ALL) Diffuse Large B-cell Lymphoma (DLBCL) Biological: CTL019

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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
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



Intervention Details:
  • Biological: CTL019
    CTL019
    Other Names:
    • tisagenlecleucel
    • Kymriah

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601442


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03601442     History of Changes
Other Study ID Numbers: CCTL019B2003I
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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

Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma