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

Safety and Efficacy of GEN3009 (DuoHexaBody® -CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts

Date Added
October 12th, 2021
PRO Number
Pro00113432
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL) or follicular lymphoma (FL) for which they previously have received treatment, but the disease is worsening or has come back and no standard approved treatment options are available to them. This study is testing an "investigational" (not yet FDA- Food and Drug Administration- approved drug) study drug called GEN3009 (DuoHexaBody®-CD37). The purpose of one arm of the study is to find out if and how well the GEN3009 works against a subject's cancer (this is called the dose expansion part). The primary purpose of the second arm of the study is to determine the maximum tolerated dose (the highest dose of the drug that does not cause unacceptable side effects) with and/or determine the recommended dose of the study drug for the next phase of studies for this drug, as well as to evaluate the safety and tolerability of the study drug (this is called the dose escalation part). The subject may be seen up to once a week during this study. The subject may remain in the study for up to five years.

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

A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

Date Added
August 24th, 2021
PRO Number
Pro00112787
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have relapsed or refractory follicular lymphoma, which means your lymphoma has worsened after treatment or has not responded to treatment. 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 called loncastuximab tesirine may be more effective treatment for relapsed or refractory follicular lymphoma than treatment with the drug idelalisib. The subject will be seen approximately once every three weeks, 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

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

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Date Added
June 3rd, 2021
PRO Number
Pro00106658
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma (NHL) that has gotten worse or come back after treatment. This study is testing an "investigational" (not yet FDA approved) study drug called Loncastuximab Tesirine. The primary purpose of this study is to evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy. The subject may remain in the study for up to 5 years, 28 days for screening period, a 16-25 week treatment period, and a follow-up period of 4 years.

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

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Date Added
May 11th, 2021
PRO Number
Pro00105780
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with an advanced type of Hodgkin lymphoma (HL) that hasn't been treated yet. Parts B and C are studying brentuximab vedotin given with 3 other drugs. Two of the drugs are chemotherapy drugs that have been used to treat cancer for a long time. One chemotherapy drug is called doxorubicin and the other is called dacarbazine. The third drug is an immunotherapy drug called nivolumab or Opdivo®. This will be the first time brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine have been tested together to treat HL. The primary purpose of this study is to assess the complete response (CR) rate (the disappearance of all signs of cancer in response to treatment) at End Of Treatment with the combination of drugs in subjects with previously untreated cHL .The subject may remain in the study for up to 2 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

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

Date Added
February 23rd, 2021
PRO Number
Pro00105358
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with a relapsed, progressive and/or refractory subtype of B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma or follicular lymphoma). The investigational drug that will be tested is called GEN3013 (DuoBody®-CD3xCD20). The purpose of the trial is to investigate the safety, tolerability and efficacy of GEN3013 in subjects with different subtypes of B-cell non-Hodgkin lymphoma (referred to as B-cell NHL). Participants can expect to be in this study for 36 weeks of treatment, plus follow up until the disease progresses.

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

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

List of Studies


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

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Date Added
September 26th, 2019
PRO Number
Pro00093207
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Lymphoma
Summary

This study is for patients with Hodgkin Lymphoma. The purpose is to decide if adding the study drug nivolumab to standard chemotherapy will extend a patient's time without disease more than or less than if adding the study drug brentuximab vedotin to standard chemotherapy.

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



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