A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy Save

Date Added
December 23rd, 2019
PRO Number
Pro00096147
Researcher
Robert Stuart

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Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients that have been diagnosed with Acute Myeloid Leukemia. The investigational drug used in this study is Uproleselan. The purpose of this study is to compare the event-free survival (EFS) of daunorubicin, cytarabine plus uproleselan versus daunorubicin and cytarabine in subjects ? age 60 with previously untreated acute myeloid leukemia. Participants can expect to receive treatment for up to 5 months and followed for up to 5 years after study completion.

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

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Save

Date Added
December 5th, 2019
PRO Number
Pro00091168
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (NSCLC). The investigational drug used in this study is durvalumab. This purpose of this study is to see how if durvalumab will work and be safe for the treatment of patients with Stage I/II Non Small Cell Lung Cancer following stereotactic body radiation therapy when compared to placebo. Participants can expect to be in the study for approximately 6 years.

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

Clinical Protocol for the Investigation of the ProSpace™ Balloon System Save

Date Added
November 26th, 2019
PRO Number
Pro00094196
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Lymphoma, Men's Health, Prostate
Summary

The ProSpace balloon is being studied to test IF it will temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating that space will reduce the radiation dose delivered to the anterior rectum. The ProSpace balloon is composed of a bioresorbable polymer material called RESOMER. RESOMER is well studied and approved for many indications. This study will show if it will maintain that space for the entire course of prostate radiotherapy treatment and then be completely absorbed by the body over time. The balloon is considered a permanent implant because it will remain in the body for at least 30 days. The ProSpace System study will collect data to demonstrate the safety and efficacy of its indication. This device is currently investigational in the United States

Institution
MUSC
Recruitment Contact
Sarah Mulhern
843-792-9321
hcc-clinical-trials@musc.edu

Study of Prostate Ablation Related Energy Devices (SPARED) Registry Save

Date Added
November 24th, 2019
PRO Number
Pro00094120
Researcher
Harry Clarke

List of Studies


Profiles_link
Keywords
Cancer, Prostate
Summary

This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This is not a treatment study. The type of prostate cancer treatment subjects received will be determined by the subject and their physician and will not be affected by their participation in this study. This research is being done is to create a comprehensive nationally-representative clinical database to facilitate the study of existing and emerging technologies for prostate cancer ablation. Ablation refers to the use of various energy sources to destroy both normal and cancerous prostate cells.

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

Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas Save

Date Added
November 18th, 2019
PRO Number
Pro00094317
Researcher
Brian Hess

List of Studies

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Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients that have been diagnosed with double-hit or double expressing lymphoma. The investigational drug in this study is venetoclax. The purpose of this study is T\to compare the progression-free survival (PFS) of R-chemotherapy plus venetoclax versus Rchemotherapy alone in MYC/BCL2 double-hit and double expressing lymphomas. Participants can expect to receive treatment for up to 18 weeks and followed by the study doctor for up to 10 years after being registered to the study.

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

Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lonalidomide as Post-Autologous STem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration Save

Date Added
November 6th, 2019
PRO Number
Pro00094224
Researcher
Amarendra Neppalli

List of Studies

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Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The investigational drugs in this study are lenalidomide and daratumumab. The purpose of this study is to compare overall survival between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma patients. Participants can expect to be on this study for up to 7 years. After 7 years, participants may be followed by telephone for up to 15 years from the time they started study treatment.

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

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Cyclophosphamide-based Conditioning for Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
November 5th, 2019
PRO Number
Pro00091874
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Cancer, Transplant
Summary

This study is for subjects that are about to receive high dose cyclophosphamide before a blood or bone marrow transplant (BMT). The investigational drug in this study is Olanzapine. This research is being done to find out whether adding olanzapine to standard medications will be helpful in controlling chemotherapy induced nausea in children. The total length of participation in this study will depend on how many days you are scheduled to receive chemotherapy, but can be up to a maximum of 2 weeks. We will review your chart for 100 days after transplant. There will be no extra visits to MUSC due to participating in the research study.

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

A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR??+/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC "CSIDE" Protocol (Conditioning SCID Infants Diagnosed Early)PBMTC NMD 1801 Save

Date Added
November 5th, 2019
PRO Number
Pro00091878
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Cancer, Infant, Pediatrics
Summary

This study is for children age 0-2 who have been diagnosed with severe combined immunodeficiency (SCID). In this study, participants will be randomized (select by chance) into groups that will decide the dose of chemotherapy they will receive, receive chemotherapy prior to a blood stem cell transplant, and have blood drawn for research tests. The purpose of this research study is to find out if lower doses of a chemotherapy drug called busulfan before stem cell transplant can help patients with SCID, and to see if the device the CliniMACS® is effective in preparing donor stem cells before the transplant. Participants can expect to be in this study for up to 3 years.

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

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA) Save

Date Added
October 22nd, 2019
PRO Number
Pro00088996
Researcher
Brian Hess

List of Studies

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Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with relapsed (the disease has gotten worse after a period of improvement) or refractory (the disease does not respond to treatment) aggressive B-cell non-Hodgkin lymphoma .The investigational therapy in this study is tisagenlecleucel treatment. This treatment includes collecting T cells from patient's blood and changing them by gene transfer to make them recognize tumor cells. The purpose of this study is to see how well tisagenlecleucel therapy treats the disease and how safe the treatment is when compared to Standard or Care treatment. Participants can expect to be in this study for up to 60 months and in follow up for up to 15 years.

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

Dermoscopic Features in Infantile Hemangiomas Save

Date Added
October 11th, 2019
PRO Number
Pro00091926
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Cancer, Cancer/Skin, Healthy Volunteer Studies, Infant, Non-interventional, Pediatrics, Rare Diseases
Summary

The goal of the study is to characterize the features of Infantile Hemangiomas before and after treatment. Certain characteristics of the hemangioma can be seen more clearly with a closer and more resolute image of the lesion (abnormal vessels etc.). Developing a greater understanding of these characteristics? may help clinicians better predict the course of infantile hemangiomas in children.

Specific aim 1: to correlate images seen on dermoscopy with regression of the hemangioma.
Specific aim 2: to provide features that may help to predict a better response to treatment.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
8437922890
Winelee@musc.edu

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