A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Date Added
December 14th, 2021
PRO Number
Pro00116496
Researcher
Brian Hess

List of Studies


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

This study is for subjects with Diffuse large B-cell lymphoma (DLBCL) that has gotten worse or come back after two or more treatments. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug combination of loncastuximab tesirine in combination with one of four other anti-cancer agents is a safe and effective treatment for relapsed or refractory B-cell Non-Hodgkin Lymphoma. Treatment will be assigned by a system in a sequence unless the subject has received the combination drug (the drug that is not locastuximab). This means the first enrolled subject will be assigned to arm C, the second to arm E, and so on. The subject will be seen approximately once a week during treatment, and may remain in the study for up to 3 years.

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

A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Date Added
October 29th, 2021
PRO Number
Pro00115669
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for participants that have been diagnosed with previously untreated CD30 Negative Peripheral T-cell Lymphomas. The purpose of this study is to determine if the effects (good or bad) of adding a study drug (duvelisib or CC-486 (azacitidine)) to the usual combination of drugs. Participants can expect to be on treatment for 18 months and followed by the study team 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 II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Patients Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC and BCL2 and/or BCL6 Rearrangements

Date Added
October 20th, 2021
PRO Number
Pro00115627
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients with newly diagnosed diffuse Large B Cell Lymphoma.
This study will help the study doctors find out if taking R-mini-CHOP plus the study drug CC-486 (oral azacitidine) is better, the same, or worse than taking the R-mini-CHOP drug combination alone. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 1 year or more after the start of the study treatment and which drug combination extends the overall survival (how long people live) of patients at 5 years after the start of the study treatment.

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

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Date Added
July 22nd, 2021
PRO Number
Pro00111458
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Leukemia, Cancer/Lymphoma
Summary

This study is for newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The purpose of this study is to find out if starting treatment with the investigational products, venetoclaz and obinutuzumab (V-O) early (before symptoms occur) affect how long you live compared to the usual approach of starting treatment after showing symptoms. Participants can expect to receive treatment for up to 12 months, until the cancer gets worse or until the side effects are too great. After study completion, participants will continue to be followed for up to 10 years.

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

Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

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

DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Date Added
August 27th, 2019
PRO Number
Pro00091613
Researcher
Toros Dincman

List of Studies

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

This study is for patients that have been diagnosed with advanced prostate cancer with bone metastases.The purpose of this research study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. The addition of radium-223 to docetaxel could have an overall survival benefit, but it could also cause side effects. The study drugs, radium-223 and docetaxel, are considered experimental drugs that are being evaluated together as a combination therapy for participants with certain solid tumors (cancer). Patients will be seen at MUSC for about 8 months. After they finish the treatment, the doctor will continue to watch the patient for side effects and follow their condition for the rest of their life, or for as long as they wish to remain on the study.

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

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

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

List of Studies


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



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