A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

BEACON: A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises

Date Added
June 13th, 2023
PRO Number
Pro00121176
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if the study drug called BEAM-101 is safe and effective in the treatment of patients with severe Sickle cell disease (SCD). The study drug, BEAM-101 is a new investigational (experimental) therapy that is the first in human use of this drug.

The study medication uses patients' own stem cells that are harvested through apheresis (process where blood is removed, stem cells collected and blood is returned), changed by genetic modification, and transplanted back into the individual through intravenous infusion to treat severe SCD.

Participation in this study is expected to last approximately 24 months, starting at time of screening, through the collection of cells, transplantation of study drug, and 15-month follow-up period. Study visits during the screen and mobilization period will vary depending on the cell collection process, in other words, the mobilization and collection period could be 3 separate visits to harvest adequate stem cells. Subjects are then hospitalized for the conditioning period, transplantation of study drug and engraftment period (when blood counts return to normal). The follow up visits after discharge from the hospital will be monthly for the first 6 months, then every other month until 24 months post transplant period.

At the end of the 24 months, all participants will be asked to enroll in the long-term extension study for a duration of 13 years making the total follow-up period of 15 years.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792.3379
dayb@musc.edu

Phase III Randomized Trial of Immunotherapy with or without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma

Date Added
February 12th, 2024
PRO Number
Pro00132402
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)

Date Added
June 14th, 2024
PRO Number
Pro00135633
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This phase III study is for participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is negative for a type of virus called human papilloma virus (HPV). If decided to participate in this study, participants will be receive either ficlatuzumab in combination with cetuximab, or placebo in combination with cetuximab. There are 3 Arms participants will be randomly assigned to: Arm 1 will receive ficlatuzumab (10mg/kg by intravenous (IV) infusion) and cetuximab (by IV infusion), Arm 2 will be given ficlatuzumab (20mg/kg by IV infusion) and cetuximab, and Arm 3 will receive placebo and cetuximab. The effectiveness of the 2 different ficlatuzumab groups (Arm 1 and Arm 2) will be compared at the first on-study scan, and the more successful Arm will began enroll more participants. This study is estimated to last approximately 5 years. Study drugs will be administered until disease progression or unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). The main risk associate with the trial are swelling of your lower legs or arms, fatigue, shortness of breath, vomiting, diarrhea or constipation, bone pain, decreased appetite, anemia, high level of liver enzymes in your blood, dizziness, infusion reactions, cardiopulmonary arrest, pulmonary (lung) toxicity, skin reactions, inflammation of the mouth, low blood counts, liver problems, infection, headache, allergic reactions, and there may be unknown risks. This treatment can not guarantee the cancer will get better, since it may stay the same or get worse. What is discovered from this study may help other people in the future. The alternative to this study is not participating in this study and receiving HNSCC in patients who have previously received immunotherapy including chemotherapy with other treatment drugs or another clinical trial.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Center
843-792-9321
hcc-clinicaltrials@musc.edu

Characterization of B-cells and wearing off phenomena in diverse populations following initiation of ublituximab

Date Added
March 4th, 2025
PRO Number
Pro00140830
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The purpose of this study is to understand differences in responses to those beginning treatment with ublituximab (Briumvi) as prescribed for Multiple Sclerosis by their treating provider. The study consists of three visits where some questions are asked about experience with Multiple Sclerosis and blood samples are drawn for genetic research and immune cell counts. While taking part in this study, some of the possible risks include those related to having blood drawn, risk of loss of confidentiality and risks related to genetic research.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-2845
line@musc.edu



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