A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML Save

Date Added
February 13th, 2018
PRO Number
Pro00072488
Researcher
Robert Stuart

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

This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.

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

Phase 2 Study of Azacitidine in Combination with Pembrolizumab in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older (?65 Years) AML Patients Save

Date Added
April 25th, 2017
PRO Number
Pro00064864
Researcher
Robert Stuart

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

This study is for patients that have been diagnosed with Relapsed/Refractory Acute Myeloid Leukemia (AML) or in Newly Diagnosed Older (?65 Years) AML Subjects. The investigational drug in this study is Azacitidine (AZA) and Pembroluzimab (KEYTRUDA). The purpose of this study is to determine the safety, tolerability and efficacy of Azacitidine (AZA) in combination with Pembrolizumab (also known as KEYTRUDA TM) in relapsed and refractory acute myeloid leukemia (AML) subjects, and also in older (?65 years) newly diagnosed AML subjects who are not candidates for intensive induction chemotherapy. Participants can expect to be in this study for up to 2 1/2 years.

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

A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia Save

Date Added
August 9th, 2016
PRO Number
Pro00057288
Researcher
Robert Stuart

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

This study is for patient that has been diagnosed with Acute Myeloid Leukemia (AML). The experimental (investigational) drug that is being tested for treatment of acute myeloid leukemia (AML), called CX-01. The purpose of this study is to find out whether or not the addition of the study drug, CX-01, to standard of care treatment for AML increases the rate of remission. Participants can expect to be in this study for approximately 18 months.

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

A phase 1, open-label, dose-escalation study of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Save

Date Added
March 8th, 2016
PRO Number
Pro00052335
Researcher
Robert Stuart

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

This study is for patients that have been diagnosed with types of non-Hodgkin lymphoma (NHL) that affect the B cells of the immune system. The investigational drug in this study is SGN-CD19B. The purpose of this study is to test the safety of different doses of SGN-CD19B when given to subjects with NHL. Participants can expect to be in this study for as long their cancer is stable or is getting better with treatment. Once they have stopped treatment, they will have follow up phone calls until the study is closed.

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

A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age. Save

Date Added
January 13th, 2015
PRO Number
Pro00039974
Researcher
Robert Stuart

Silhouette
Keywords
Cancer/Leukemia
Summary

This study is for patients with newly diagnosed myeloma. The study will be looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma.

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

A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML) Save

Date Added
April 28th, 2014
PRO Number
Pro00033666
Researcher
Robert Stuart

Silhouette
Keywords
Cancer/Leukemia
Summary

This study is for adult male and female patients with previously untreated acute myeloid leukemia (AML). The purpose of this study is to compare the effects, good and/or bad of three drug combinations. The first combination is the standard treatment of daunorubicin plus AraC. The second combination is another standard treatment of idarubicin plus AraC. The third combination will add the drug vorinostat to the standard IA therapy. The study team wants to see if the study treatments will get rid of leukemia cells and keep them from coming back for patients who may benefit from stem cell transplant. They also want to find stem cell transplant donors for patients who might benefit from a transplant according to standard practice, beginning at the time patients register for the study. Participants will be asked to take induction treatment for 1-2 months. If a participant gets consolidation, it could take from 1-4 months. Participants may go on to transplant any time in the next year after he/she goes into remission. After participants are finished with the study treatment, the study doctor will ask them to visit the office for follow-up exams for at least 5 years from the time they go into remission.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Robert Stuart

Silhouette
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
?Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
?Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

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

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