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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

Clinical Trial Details

If you will be receiving Tisagenlecleucel as standard-of-care and if you meet the following qualifications below, you may receive Tisagenlecleucel as an out-of-specifications product through the Managed Access Program (MAP).This is a special access program for patients with ALL or large B cell lymphoma who:

  1. Have already decided to receive Tisagenlecleucel and have undergone leukapheresis (a process to remove immune cells from your blood) but for whom there was some problem in the leukapheresis product - either before the process to convert your immune cells to Tisagenlecleucel or after that process - such that commercial specifications of the Tisagenlecleucel product label were not met
  2. Are not candidates for repeat leukapheresis (per the treating physician assessment)
  3. For whom no comparable or satisfactory alternative treatment is available.

T-cells (a type of white blood cell) have been removed from your blood and modified in order to target the leukemia and or lymphoma and then will be returned back to you. The T-cells will be changed in a way that can allow them to identify and possibly kill your tumor cells which are B-cells. The modification of the T-cells is done by a process called gene transfer which results in genetic modification to the T-cells taken from your body. The modified T-cells are called CTL019 cells or Tisagenlecleucel.

Key Eligibility: 

Inclusion Criteria

  • Open to men and women above the age of 18 who have been diagnosed with lymphoblastic leukemia (ALL) or large B-cell lymphoma
  • 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

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

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1712018794

ClinicalTrials.gov:

NCT03601442

Sponsor:

CCTL019B2003I

Status

Open to Enrollment

Age Group

Adult

Sponsor