Janssen Research & Development, LLC
Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
Conditions: Multiple Myeloma
The objective of this study is to provide early access to daratumumab treatment andcollect additional safety data while the medication is not commercially available oravailable through another protocol for subjects with multiple myeloma who have receivedat least 3 prior lines of therapy including a proteasome inhibitor (PI) and animmunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and anIMiD.
Cook Group Incorporated
Zenith® TX2® Low Profile TAA Endovascular Graft
Conditions: Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collectconfirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA EndovascularGraft is indicated for the treatment of patients with a descending thoracic aorticaneurysm or penetrating ulcer and has an anatomy suitable for repair.
Cook Research Incorporated
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
Conditions: Aortic Dissection
The Zenith® Dissection extended study is to collect confirmatory safety and effectivenessdata on the Zenith® Dissection Endovascular System in the treatment of acute, complicateType B aortic dissection.
Taiho Oncology, Inc.
Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
Conditions: Colorectal Cancer Metastatic
The objective of the program is to provide access to TAS-102 to patients with metastaticcolorectal cancer who are refractory to or failing standard chemotherapy, are new totherapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.
Eisai Inc.
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
Conditions: Differentiated Thyroid Cancer
This Expanded Access Program (EAP) consists of a Prerandomization Phase and aRandomization Phase. Only subjects with radioiodine-refractory DTC who fulfill theeligibility criteria will be treated. These subjects will be treated until progression ofdisease or unacceptable toxicity.
Boehringer Ingelheim
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
Conditions: Idiopathic Pulmonary Fibrosis
To provide early access and to evaluate the safety and tolerability of nintedanib inpatients with idiopathic pulmonary fibrosis (IPF).
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.
Gilead Sciences
Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia
Conditions: Chronic Lymphocytic Leukemia (CLL)
This study is to provide idelalisib (IDELA) to individuals with relapsed, previouslytreated chronic lymphocytic leukemia (CLL) who have limited treatment options and are noteligible for other Gilead-sponsored studies.
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.
BioMarin Pharmaceutical
BMN 110 US Expanded Access Program
Conditions: Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
The Expanded Access Program (EAP) is an open-label, multicenter program to: 1. Provide patients who have been diagnosed with Mucopolysaccharidosis IVA (MPS IVA) access to BMN 110 until commercial product is available 2. Collect additional information on the safety and tolerability of BMN 110 administration in patients with MPS IVAPatients enrolled in the EAP will receive 2.0 mg/kg intravenous infusions of BMN 110every week during the program.