A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma

Date Added
December 10th, 2019
PRO Number
Pro00095145
Researcher
Brian Hess

List of Studies

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

This study is for adult male and female subjects that have been diagnosed with a blood cancer called Hodgkin Lymphoma (HL) that has gotten worse or come back after treatment with available therapies known to provide clinical benefit. The investigational drug in this study is Camidanlumab Tesirine (Cami, ADCT-301) and will be administered intravenously. The purpose of this Phase 2 study is to evaluate the effectiveness and safety of the investigational drug Cami (ADCT-301) in subjects with HL that has gotten worse or come back after treatment. Participants can expect to be in this study for a total of 4 years; 1 year in treatment (Seen 4 times per month to begin with and then every 6-9 weeks at MUSC, while you remain on treatment) and 3 years in follow up.

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

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)

Date Added
October 22nd, 2019
PRO Number
Pro00088996
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 (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

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

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 70 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Date Added
July 3rd, 2019
PRO Number
Pro00089973
Researcher
Brian Hess

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients that have been diagnosed with chronic lymphocytic leukemia (CLL). The investigational drug used in this study is venetoclax in addition to standard treatment of ibrutinib plus obinutuzumab. The purpose of this study is to compare the progression-free survival (PFS) between control treatment and experimental treatment strategies: ibrutinib/obinutuzumab (IO) with ibrutinib maintenance (IM) versus ibrutinib/venetoclax/obinutuzumab (IVO) regardless of IM or observation. Participants can expect to be on treatment for up to 1 year and followed by their physician for up to 10 years.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Date Added
November 13th, 2018
PRO Number
Pro00083282
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). The investigational drug in this study is loncastuximab tesirine (ADCT-402). The purpose of this Phase 2 study is to evaluate the effectiveness and safety of loncastuximab tesirine in subjects with DLBCL that has not responded to treatment or has come back after treatment.Treatment will occur every 3 weeks. The follow up treatment period will last up to approximately 3 years.

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

Oral Azacitidine (CC-486) Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Date Added
October 23rd, 2018
PRO Number
Pro00082843
Researcher
Brian Hess

List of Studies

Keywords
Cancer/Lymphoma
Summary

The overall goal of this research study is to find out if adding a drug called azacitidine (AZA) to the standard of care R-ICE chemotherapy before an autologous stem cell transplant (ASCT) is safe and effective in patients with diffuse large B-cell lymphoma (DLBCL). R-ICE is a combination chemotherapy using rituximab, ifosfamide, carboplatin, and etoposide phosphate.

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

A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission

Date Added
July 2nd, 2018
PRO Number
Pro00079363
Researcher
Brian Hess

List of Studies

Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients who have mantle cell lymphoma. The investigational drugs used in this study are rituxan hycela and rituximab. The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR). Participants can expect to be in this study for up to 3 years and then followed for up to 10 years to monitor their health.

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

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Date Added
February 27th, 2018
PRO Number
Pro00073226
Researcher
Brian Hess

List of Studies

Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients that have been diagnosed with follicular lymphoma. The investigational drugs used in this study are TGR-120 and Lenalidomide.The purpose of this study is to compare any good and bad effects of using the different drugs in combination with an antibody (Obinutuzumab). Participants can expect to be in this study for up to 5 years. There are 3 study groups. Groups 1 and 2 will get treatment on the study for 48 weeks (about 11 months). Group 3 will get treatment on the study for 42 weeks (about 9 ½ months). After you finish treatment on the study, your doctor will continue to watch you for side effects and follow your condition. At a minimum, you will go to the doctor's office every 3 months for the first 2 years, then every six months until 5 years from the time you started the study.

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



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