A Phase I, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 3654 in patients with Intermediate-2 or High-Risk Primary or Secondary Myelofibrosis

Date Added
February 25th, 2020
PRO Number
Pro00096184
Researcher
Robert Stuart

List of Studies

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

This study is for subjects that have intermediate-2 or high risk, primary or secondary Myelofibrosis for which standard therapy has proven ineffective, for which their body cannot tolerate the standard therapy, or for which there is no standard therapy. This study is testing an "investigational" (not yet FDA approved drug) study drug called TP-3654. The primary purpose of this study is to evaluate the safety of TP-3654 at different doses to find out what effects, if any, it has on people. The subject may remain in the study for up to 1 year. They may receive additional treatment beyond 1 year if they are tolerating and showing benefit from the treatment.

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

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Date Added
February 6th, 2020
PRO Number
Pro00094221
Researcher
Robert Stuart

List of Studies

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

This study is for subjects that are newly diagnosed with acute myeloid leukemia with FLT3 mutations. The investigation drug in this study is crenolanib. The purpose of this study is to compare the efficacy an investigational drug called crenolanib (also referred to as study drug in this consent) with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. The estimated average time that a subject will receive study drug on this study is about 12 months. The subject will take study drug as long as there is clinical benefit (that is their leukemia does not progress) and they are able to tolerate the study drug.

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

A Phase 1b trial of CPX-351 Lower Intensity Therapy (LIT) plus Venetoclax as First Line Treatment for Subjects with AML who are Unfit for Intensive Chemotherapy

Date Added
January 14th, 2020
PRO Number
Pro00094444
Researcher
Robert Stuart

List of Studies

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

This study is for subjects with newly diagnosed Acute Myeloid Leukemia (AML). The investigational drug in this study is CPX-351(marketed as Vyxeos). The purpose of this research study is to find out whether a reduced dosing of CPX-351, given in combination with Venetoclax, is safe and effective when given to subjects with newly diagnosed AML who cannot tolerate intensive chemotherapy due to age or other health conditions. Subjects can expect to be in this study for approximately 1 year.

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

A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Date Added
December 23rd, 2019
PRO Number
Pro00096147
Researcher
Robert Stuart

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients that have been diagnosed with Acute Myeloid Leukemia. The investigational drug used in this study is Uproleselan. The purpose of this study is to compare the event-free survival (EFS) of daunorubicin, cytarabine plus uproleselan versus daunorubicin and cytarabine in subjects ≥ age 60 with previously untreated acute myeloid leukemia. Participants can expect to receive treatment for up to 5 months and followed for up to 5 years after study completion.

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

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

List of Studies

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 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)

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

List of Studies

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

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

List of Studies

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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