Novartis Pharmaceuticals
CTL019 Out of Specification MAP for ALL or DLBCL Patients
Conditions: Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL)
Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblasticleukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out ofspecification leukapheresis product and/or manufactured tisagenlecleucel out ofspecification for commercial release.
HbO2 Therapeutics LLC
Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia
Conditions: Anemia Severe
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, orreduce the need for red blood cell transfusions in anemic patientsThis is an expanded access IND protocol, and will provide treatment with HBOC-201 toseverely anemic adults for whom blood is not an option
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Individual Patient Compassionate Use of Fedratinib
Conditions: Myelofibrosis
This is an expanded access program (EAP) for eligible participants designed to provideaccess to fedratinib.Expanded access is only available in markets where fedratinib is not yet approved.
Gradalis, Inc.
Expanded Access of Vigil in Solid Tumors
Conditions: Solid Tumor, Ewing Sarcoma, Ewing's Tumor Metastatic, Ewing's Sarcoma Metastatic, Advanced Gynecological Cancers, Ovarian Cancer, Cervical Cancer, Uterine Cancer
This is an expanded access study involving an investigational product named Vigil. Vigilis considered immunotherapy. Patients who participated in another clinical trialsponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standardoperation, however failed the criteria to enroll in the other clinical trial to receiveVigil are eligible to screen for this expanded access trial to receive the Vigil madefrom their cancer cells.In this study, eligible participants will receive intradermal (under the skin) injectionsof Vigil, once every 4 weeks (28 days) for 1-12 doses, depending on the number of dosesthat was made from the cancer cells and if the participant is clinically stable. Duringthe treatment portion of the study, in addition to receiving Vigil injections,participants will also have a physical exam, blood collection for routine and researchtests, and assessment of medications, adverse events, and performance status informationwill be collected. Radiological tumor assessments will be performed every 3 months fromCycle 1. Once treatment ends, participants will continue to be seen in the clinic every 3months for similar assessments until disease progression occurs. After diseaseprogression, participants will be contacted by phone 4 times a year to determine poststudy treatment and survival status information.
University of Texas, Southwestern Medical Center at Dallas
Intermediate Expanded Access Protocol CNMAu8.EAP03
Conditions: Multiple Sclerosis
This is a single-center intermediate expanded access program to provide access to theinvestigational product, CNM-Au8, up to 25 participants diagnosed with MultipleSclerosis.