A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients

Overview

About this study

The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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..
  • Many 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Mohamed Kharfan Dabaja, M.D., M.B.A.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Januario Castro, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Richard Bram, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453747

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