A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients

Date Added
March 25th, 2022
PRO Number
Pro00119338
Researcher
Irl Greenwell

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients that have been diagnosed with untreated mantle cell lymphoma (MCL). The investigational drug is Acalabrutinib. Acalabrutinib is investigational for treating newly diagnosed MCL. The purpose of this study is to compare the usual treatment of 1) bendamustine, rituximab, and high dose cytarabine to using 2) bendamustine, rituximab, high dose cytarabine, and acalabrutinib and 3) bendamustine, rituximab, and acalabrutinib. Participants can expect to be on study for a total of 6 months of treatment and followed by the study team for up to 10 years or until disease progression.

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

An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

Date Added
January 11th, 2022
PRO Number
Pro00116530
Researcher
Irl Greenwell

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) Epstein-Barr Virus-Positive (EBV+) lymphomas.

The investigational drug in this study is Nanatinostat. Investigational means it is not approved by the United States' Food and Drug Administration (US FDA). Nanatinostat is a tablet that will be taken by mouth once a day.

The purpose of this research study is to determine the effectiveness and safety of the combination therapy, nanatinostat and valganciclovir, on treating lymphoma cancers. Valganciclovir is an approved anti-viral drug (a drug that fights against virus in your body), which has been used in the prevention and treatment of infection caused by a virus called cytomegalovirus (CMV), which is similar to Epstein-Barr virus (EBV). The safety and effectiveness of nanatinostat on its own will also be reviewed in a small subset of patients.

Participants can expect to receive treatment until disease progression, unacceptable toxicity/ side effects, or participants withdraw. Participants can expect to be in follow up for up to 5 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
Irl Greenwell

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 multi-center phase Ib trial evaluating the safety and efficacy of lacutamab in patients with relapse peripheral T-cell lymphoma that express KIR3DL2

Date Added
August 24th, 2021
PRO Number
Pro00113053
Researcher
Irl Greenwell

List of Studies


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

This study is for subjects that have been diagnosed with peripheral T-cell lymphoma (PTCL) and have received at least one prior systemic therapy for their disease. This study is testing an "investigational" (not yet FDA approved drug) study drug called Lacutamab (IPH4102). The primary purpose of this study is to evaluate the safety and effectiveness of lacutamab. The subject may remain in the study until their disease progresses or they have developed unacceptable toxicity secondary to lacutamab and can expect to be in follow-up for 1 year if they discontinue treatment in the first year.

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

A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Date Added
March 19th, 2021
PRO Number
Pro00105076
Researcher
Irl Greenwell

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) that has come back or did not get better with your last treatment. The investigational drug in this study is brentuximab vedotin. The purpose of this study is to test if brentuximab vedotin, lenalidomide, and rituximab given together work to treat DLBCL and what the side effects are. Participants can expect to be in this study for up to 2.5 years.

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

A PHASE II EVALUATION OF BENDAMUSTINE, OBINUTUZUMAB AND VENETOCLAX IN PATIENTS WITH UNTREATED MANTLE CELL LYMPHOMA

Date Added
January 28th, 2020
PRO Number
Pro00095207
Researcher
Irl Greenwell

List of Studies


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

This study is for adult male and females that have been diagnosed with mantle cell lymphoma. The drugs in this study include the combination of bendamustine, obinutuzumab and venetoclax (also called "BOV"). They are each approved for treatment, but is considered investigational (not approved by the FDA), when combined. The purpose of this study is to find out if BOV is effective and safe for the treatment of people with mantle cell lymphoma. Participants can expect to be in this study for approximately 51/2 years.

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

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)

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

List of Studies


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



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