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NCT ID: NCT03601442 Available - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

CTL019 Out of Specification MAP for ALL or DLBCL Patients

Start date: n/a
Phase:
Study type: Expanded Access

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

NCT ID: NCT03581240 Available - Neuroblastoma Clinical Trials

An Intermediate Expanded Use Trial of DFMO

Start date: n/a
Phase:
Study type: Expanded Access

To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.

NCT ID: NCT03496051 Available - Clinical trials for Hepatocellular Carcinoma

Single Patient Access (Compassionate Use) for Continued Treatment of RO7070179 for Adult Subjects With Advanced Hepatocellular Carcinoma (HCC)

Start date: n/a
Phase:
Study type: Expanded Access

This is a single-patient access (also referred to as Compassionate Use) setting for a patient who has been treated and benefited from RO7070179 while participating in a clinical study of RO7070179. The patient will receive the dose of RO7070179 at 6 mg/kg/week by IV infusion. Treatment cycles will be defined as 42 (6 weeks) days.

NCT ID: NCT03327467 Available - Cerebral Palsy Clinical Trials

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.

NCT ID: NCT03145545 Available - Leukemia Clinical Trials

Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC

Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.

NCT ID: NCT03015844 Available - Neuroblastoma Clinical Trials

A Compassionate Use/Expanded Access Protocol Using 131I-MIBG Therapy for Patients With Refractory Neuroblastoma and Metastatic Pheochromocytoma

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access protocol/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Response rate, toxicity, and time to progression and death will be evaluated.

NCT ID: NCT02934282 Available - Anemia Clinical Trials

HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.

NCT ID: NCT02684474 Available - Anemia Clinical Trials

Expanded Access Protocol Using HBOC-201

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.

NCT ID: NCT02632994 Available - Cancer Clinical Trials

Master Rollover Protocol for Continued Safety Assessment of Study Drug

Start date: n/a
Phase:
Study type: Expanded Access

This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.

NCT ID: NCT02567175 Available - Clinical trials for Gastroesophageal Reflux

Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders

Start date: n/a
Phase:
Study type: Expanded Access

FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with Domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to be eligible to receive Domperidone. This program facilitates availability of investigational drugs, (such as Domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.