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NCT ID: NCT03620318 Available - FLT3-ITD Mutation Clinical Trials

Individual Patient Compassionate Use of Crenolanib

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

Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis. Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)

NCT ID: NCT03626285 Available - Malignant Neoplasm Clinical Trials

Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders

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

This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.

NCT ID: NCT03631056 Available - Vascular Diseases Clinical Trials

Individual Patient Expanded Access for Human Acellular Vessel (HAV)

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

Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an HAV clinical study

NCT ID: NCT03633604 Available - Anemia Severe Clinical Trials

Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia

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

HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option

NCT ID: NCT03676049 Available - Clinical trials for Drug Resistant Epilepsy

Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)

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

This is a treatment study under an approved Expanded Use IND protocol for using Cannabidiol (CBD) Extract. CBD will be used for the treatment of 5-10 children with drug resistant epilepsy. The CBD used in this study is prepared at the University of Mississippi under approval of the National Institute on Drug Abuse (NIDA) for its preparation and FDA approval under an expanded access mechanism on a compassionate use basis. The target patient population is who would otherwise have no appropriate remaining treatment modality left. These are patients for whom the risks of a relatively untested product are outweighed by the potential benefit. Using seizure-diaries to register seizure frequency, drug log and questionnaire to measure parent/patient quality of life and side effects will be assessed in each visit. Visits are: baseline, 4, 8, and 12 weeks visit. A 24 weeks visit (6 months) will be performed if the patient is stable on therapy during the 3 initial months and want to continue on the study for 3 more months. CBD will be administered as an adjunct to all current anti-epileptic therapies.

NCT ID: NCT03720626 Available - Sickle Cell Disease Clinical Trials

MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients

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

The purpose of this Cohort Treatment Plan is to allow access to crizanlizumab (SEG101) for eligible patients diagnosed with sickle cell disease (SCD) to prevent or reduce the frequency of vaso-occlusive crises (VOC). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

NCT ID: NCT03723148 Available - Myelofibrosis Clinical Trials

Individual Patient Compassionate Use of Fedratinib

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

This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib. Expanded access is only available in markets where fedratinib is not yet approved.

NCT ID: NCT03746899 Available - Clinical trials for Critical Limb Ischemia (CLI)

Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)

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

This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI patients who cannot participate in the ongoing research trial and who seek exploratory treatment options. This program includes FDA-authorized cost recovery, meaning payment is required to cover a portion of the costs of delivering product and complying with regulatory obligations.

NCT ID: NCT03763370 Available - Multiple Myeloma Clinical Trials

Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

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

Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

NCT ID: NCT03763604 Available - Clinical trials for Metastatic Breast Cancer

Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

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

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.