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.
Giselle Sholler
An Intermediate Expanded Use Trial of DFMO
Conditions: Neuroblastoma, Medulloblastoma, Typical Teratoid Rhabdoid Tumor, Embryonal Tumor With Abundant Neuropil and True Rosettes, Ependymoblastoma, Medulloepithelioma
To provide DFMO in an expanded use setting to subjects with relapsed rare tumors withincreased LIN28 expression or MYCN amplification or up regulation of ornithinedecarboxylase.
Eli Lilly and Company
Master Rollover Protocol for Continued Safety Assessment of Study Drug
Conditions: Cancer
This study is for patients who have participated in a previous study and who continue toreceive benefit to have continued access to study drug and/or treatment.
Northwest Biotherapeutics
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
Conditions: GBM, Glioblastoma Multiforme
The study is an open-label expanded access study for patients for whom vaccine wasmanufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screeningprocess, but who subsequently failed to meet specific enrollment criteria. Patients willreceive therapy per investigator discretion (standard of care) as well as active vaccineper the 020221 protocol administration schedule. It is estimated that approximately 99patients will enroll in this study.
Joanne Kurtzberg, MD
Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants
Conditions: Hematologic Malignancies, Inborn Errors of Metabolism Disorders, Immune Deficiencies
The objective of this study is to make T-cell depleted stem cells from a family memberwho is a half match (haplo-identical) available on an expanded access basis to patientsreceiving one or two unrelated cord blood transplants who are at a higher risk of notengrafting in a safe amount of time. The purpose of the related stem cells is the givethe bone marrow a "jump start" towards recovery. Ultimately, the cord blood cells willgrow and permanently rescue the bone marrow.
Jubilant DraxImage Inc.
Expanded Access Protocol Using 131I-MIBG
Conditions: Neuroblastoma, Pheochromocytoma, Paraganglioma
Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG forpatients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do notqualify for available treatments, or where approved treatment is not commerciallyavailable.
Eyetech Pharmaceuticals
A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema
Conditions: Diabetic Macular Edema
Establish the efficacy of initial high frequency loading of intravitreal pegaptanibbi-weekly during the initial treatment period when the VEGF levels are the greatest andthen gradually extending the administration frequency to monthly as homeostasis ensuesfor the treatment of DME, as measured by best-corrected visual acuity.
AIM ImmunoTech Inc.
Ampligen in Chronic Fatigue Syndrome
Conditions: Chronic Fatigue Syndrome
This is an open label study of Ampligen in patients with chronic fatigue syndrome.