Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
1
Study Matches
Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release
This study is to provide access to CTL019 for ALL or large B-cell lymphoma patients who are either out of manufactured specifications or out of specification leukapheresis product who would otherwise not be able to be treated with CTL019 due to commercial restrictions.
This means these manufactured cells are not able to be used commercially and insurance will not pay or contribute to paying for the product.
patient to be treated has a serious or life threatening disease or condition and no comparable alternative therapy is available patient is not eligible or able to enroll in a clinical trial potential benefit to justify potential risk of the treatment use provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial access to provision of investigational product is allowed per local laws and regulations
Exclusion Criteria:
product can be commercially manufactured per the specifications evidence of CD19 negative disease in patients with B-cell ALL active Hepatitis B, active or latent Hepatitis C, or HIV positivity uncontrolled active infection or inflammation pregnant or nursing women