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
J
Jodi Skiles
Primary Investigator
Enrolling By Invitation
1-25 years
All
Phase
N/A
2 Locations
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
The purpose of this Managed Access Program (MAP), which is an intermediate size patient population Expanded Access, is to allow treatment with tisagenlecleucel (CTL019) for eligible patients diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of the following criteria: are 1) consistent with the approved prescribing information, 2) unable to receive commercially manufactured product due to failure of the incoming apheresis material to meet acceptance specifications or final outgoing product to meet the commercial release specifications or other specification within the prescribing information, and 3) where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product. The requesting treating physician submitted a request to Novartis to access tisagenlecleucel that does not meet commercial specifications, which was reviewed and approved by the medical team experienced with tisagenlecleucel and the indication.
The purpose of this Managed Access Program (MAP), which is an intermediate size patient population Expanded Access, is to allow treatment with tisagenlecleucel (CTL019) for eligible patients diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of the following criteria: are 1) consistent with the approved prescribing information, 2) unable to receive commercially manufactured product due to failure of the incoming apheresis material to meet acceptance specifications or final outgoing product to meet the commercial release specifications or other specification within the prescribing information, and 3) where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product. The requesting treating physician submitted a request to Novartis to access tisagenlecleucel that does not meet commercial specifications, which was reviewed and approved by the medical team experienced with tisagenlecleucel and the indication.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Riley
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Age: Between 1 Day - 25 Years
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Gender: All
Inclusion Criteria:
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP).
- - Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label.
- Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). These may include:
- pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
- adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
- Informed consent must be obtained prior to treatment
- The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications
- Contraindications as per the approved local label or the IB.
Updated on
14 Sep 2024.
Study ID: 1811337984, PHO-NOVARTISMAPS-SKILES
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