Boehringer Ingelheim
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
Conditions: Lung Diseases, Interstitial
This Expanded Access Program is intended to facilitate the availability of OFEV topatients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (nonIPF-ILD) with a progressive clinical course despite Standard of Care treatment and forwhom no satisfactory authorised alternative therapy exists or who cannot enter a clinicaltrial.
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.
CellTrans Inc.
Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
Conditions: Type 1 Diabetes Mellitus
A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy ofallogeneic islet transplantation in improving glycemic control in Type 1 diabeticpatients using the UIC protocol.The objective in offering expanded access to donislecel(allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment ofbrittle T1D is to bridge the gap between completed clinical trials and marketing (i.e.approval by the FDA of a biological license application). Expanded access will allowclinical trial subjects, as well as patients outside a clinical trial, to receivetreatment. New patients participating in the expanded access protocol are required tomeet exclusion and inclusion criteria.
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.
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
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.
AstraZeneca
An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1
Conditions: NF type1 With Inoperable Plexiform Neurofibromas
This will be an open-label, single-arm, multicenter intermediate access protocol whichprovides treatment access to selumetinib for eligible patients with neurofibromatosistype 1 (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN)without any alternative therapeutic options. All patients will continue to receive drugwhile they are deriving clinical benefit.Approximately 100 patients in the US will be treated as part of this protocol
Genentech, Inc.
An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors
Conditions: Hemophilia A
This open-label, multicenter expanded access program (EAP) is designed to provideemicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitorsbefore it is commercially available in the United States for the indication of hemophiliaA with FVIII inhibitors. Discontinuation may occur earlier if participant or physiciandecides to discontinue treatment or the sponsor discontinues emicizumab clinicaldevelopment.
Kite, A Gilead Company
Axicabtagene Ciloleucel Expanded Access Study
Conditions: Relapsed/Refractory Diffuse Large B Cell Lymphoma, Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, Relapsed/Refractory Transformed Follicular Lymphoma, Relapsed/Refractory High-Grade B-Cell Lymphoma
A multicenter, open-label expanded access protocol for the treatment of subjects withrelapsed/refractory large B-cell lymphoma.Subjects who received an infusion of axicabtagene ciloleucel will complete the remainderof the 15 year follow-up assessments in a separate long-term follow-up study,KT-US-982-5968
Incyte Corporation
An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Conditions: Graft-versus-host Disease (GVHD)
To provide ruxolitinib through an expanded access program for the treatment ofgraft-versus-host disease (GVHD) in United States to patients who are ineligible orunable to participate in any actively enrolling Incyte-sponsored clinical studies forruxolitinib in the treatment of GVHD.