A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL) Save

Date Added
March 12th, 2019
PRO Number
Pro00086655
Researcher
Irl Greenwell

List of Studies

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Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients that have been diagnosed with chronic lymphocytic leukemia (CLL). The investigational drugs in this study are ibrutinib, obinutuzumab and venetoclax. The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a combination treatment of ibrutinib and obinutuzumab plus the study drug, venetoclax.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy Save

Date Added
January 9th, 2019
PRO Number
Pro00084750
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer/Leukemia, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with Leukemia or Lymphoma. and have been treated on one of the following studies: Pediatric Oncology Group (POG) 9404, 9425, 9426, or Dana Farber Cancer Institute (DFCI) ALL Consortium 95-01. The purpose of this study is to look at the heart function of patients selected by change to get DRZ compared to the heart function of patients selected by chance not to get DRZ. In this study, they will also look at gender, age at cancer diagnosis, current age, dose of chemotherapy, and if chest radiation influences the risk of early heard damage. Participants in this clinical trial are expected to come to one clinic visit.

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

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones Save

Date Added
October 3rd, 2018
PRO Number
Pro00082665
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients who have been diagnosed with a form of Acute Lymphoblastic Leukemia (ALL) called Philadelphia chromosome positive (Ph+) ALL. The purpose of this study is to compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. A drug called imatinib in combination with chemotherapy will be given. Participants can expect to be in this study for up to 2 years and their health followed for up to 10 years.

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

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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome Save

Date Added
November 9th, 2017
PRO Number
Pro00067992
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myeloid Leukemia (AML) and Down Sydnrome (DS). The purpose of this study is to find out if subjects with standard risk DS AML can be treated with less treatment and still have successful outcomes as well as to find out if subjects with high risk DS AML can be successfully treated with stronger chemotherapy. Participants can expect to be in this study for about 6 months.

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

List of Studies

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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

List of Studies

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

List of Studies

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

USO 14206: A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL). Save

Date Added
March 29th, 2015
PRO Number
Pro00043579
Researcher
Suzanne Fanning

List of Studies

Keywords
Blood Disorders, Cancer/Leukemia
Summary

This study is for patients who have been previously treated for Chronic Lymphocytic Leukemia (or CLL), and have at least one high-risk cytogenetic abnormality (17p deletion, 11q deletion and/or P53 gene mutation).
The study is being done to determine how effective the combination of an investigational drug (ublituximab) and another currently FDA approved drug ibrutinib (also referred to as Imbruvica®) is when given to patients without causing serious side effects.

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

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