A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

Silhouette
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway?Mutant Acute Lymphoblastic Leukemia Save

Date Added
February 13th, 2018
PRO Number
Pro00071934
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with High Risk B-Lymphoblastic Leukemia (HR B-ALL). The investigational drug in this study is Ruxolitinib. The purpose of this study is to find out if the study drug, ruxolitinib, in combination with standard HR B-ALL treatment is safe and effective in children, adolescents, and young adults with HR B-ALL. Participants can expect to be in this study for the treatment period of approximately 26 months (females) or 38 months (males) plus the post-treatment follow-up. Subjects are considered on study during the post-treatment follow-up period until the subject is deceased, lost to follow-up, or until the study is completed. Subjects in this study will be followed until all enrolled subjects have been followed for 3 years from Day 1 or are deceased or lost to follow-up.

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML Save

Date Added
February 13th, 2018
PRO Number
Pro00072488
Researcher
Robert Stuart

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

This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.

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

A PHASE 1/2A OPEN-LABEL, MULTI-DOSE, MULTI-CENTER ESCALATION AND EXPLORATORY STUDY OF CERDULATINIB (PRT062070) IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL) OR B-CELL OR T-CELL NON-HODGKIN LYMPHOMA (NHL) Save

Date Added
January 10th, 2017
PRO Number
Pro00061324
Researcher
Brian Hess

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

This study is for patients that have been diagnosed with 1 of the following types of cancer : Chronic Lymphocytic Leukemia (CLL), Small-Cell Lymphocytic Lymphoma (SLL), or of Non-Hodgkin Lymphoma (NHL) of which there are 2 mains types: B-Cell NHL or T-Cell NHL. The investigational drug being studied is PRT062070; it is also called "cerdulatinib."The primary purpose of Phase 2a of this study is to assess safety and the activity of the study drug in patients who have CLL, SLL, or B-cell NHL, or T-cell NHL. You will take the study drug until you withdraw your agreement to continue to take part in this study, your cancer becomes worse, you have severe side effects, the research study ends, or you have completed dosing with the study drug and all follow-up study visits.

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

URCC 14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral therapy for Treating Insomnia in Cancer Survivors Save

Date Added
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life.

Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

USO 15005: informCLL™: A Disease Registry for Patients with Chronic Lymphocytic Leukemia (PCYC-1134M) Save

Date Added
February 14th, 2016
PRO Number
Pro00052196
Researcher
Suzanne Fanning
Keywords
Cancer/Leukemia
Summary

Patients in this study have been diagnosed with CLL or SLL and will be starting or have recently started treatment for CLL or SLL.
This observational study is research that aims to collect data over time on how a certain treatment is used and its effects, without any change to normal care. This means that routine clinical practice is followed. Any treatment given follows normal routine and is decided by you and your doctor. This study will not alter or interfere with the normal care patients receive in any way.
The purpose of this observational study is to build a registry that will provide information on regimens used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Sometimes CLL and SLL can return (relapse) after treatment, or get worse (progress) during a course of treatment. If this happens, a new treatment is needed. The registry will collect the following information from patients regular care medical records for review and study: patients medical history and medications, patients cancer treatment and side effects, the results of patients regular care laboratory tests, and the results of cancer care and treatment procedures performed as part of patients regular care. The registry study will also collect information on how out-of-pocket costs impact cancer care and treatment. The registry that will be built from information gathered from this study can help doctors decide what to do in situations when a new treatment is needed. Importantly, they can also gather information to help doctors learn which treatments are most effective in these situations.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus Host-Disease Save

Date Added
March 17th, 2015
PRO Number
Pro00041659
Researcher
Amarendra Neppalli

Silhouette
Keywords
Cancer/Leukemia
Summary

The purpose of this study is to compare three different combinations of treatment plans to see whether one or more of them are better than a standard transplant procedure. The procedures being studied have the objective to reduce the occurrence of chronic GVHD.

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

Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for Childhood Hematologic Malignancies Save

Date Added
February 3rd, 2015
PRO Number
Pro00041150
Researcher
Michelle Hudspeth

Silhouette
Keywords
Cancer/Leukemia, Cancer/Lymphoma
Summary

This clinical trial is being done to collect information about various long-term effects commonly seen in children who survive a stem cell transplant. In particular, information about renal (kidney), cardio-metabolic (heart disease and diabetes) and skeletal (bone) long-term effects will be collected for two years after transplant.

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

A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age. Save

Date Added
January 13th, 2015
PRO Number
Pro00039974
Researcher
Robert Stuart

Silhouette
Keywords
Cancer/Leukemia
Summary

This study is for patients with newly diagnosed myeloma. The study will be looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma.

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

A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML) Save

Date Added
April 28th, 2014
PRO Number
Pro00033666
Researcher
Robert Stuart

Silhouette
Keywords
Cancer/Leukemia
Summary

This study is for adult male and female patients with previously untreated acute myeloid leukemia (AML). The purpose of this study is to compare the effects, good and/or bad of three drug combinations. The first combination is the standard treatment of daunorubicin plus AraC. The second combination is another standard treatment of idarubicin plus AraC. The third combination will add the drug vorinostat to the standard IA therapy. The study team wants to see if the study treatments will get rid of leukemia cells and keep them from coming back for patients who may benefit from stem cell transplant. They also want to find stem cell transplant donors for patients who might benefit from a transplant according to standard practice, beginning at the time patients register for the study. Participants will be asked to take induction treatment for 1-2 months. If a participant gets consolidation, it could take from 1-4 months. Participants may go on to transplant any time in the next year after he/she goes into remission. After participants are finished with the study treatment, the study doctor will ask them to visit the office for follow-up exams for at least 5 years from the time they go into remission.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

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