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
Praneeth Baratam

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 Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Praneeth Baratam

List of Studies

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

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

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

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Date Added
January 11th, 2022
PRO Number
Pro00117607
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects that have been diagnosed with AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome). This study is testing an "investigational" (not yet FDA approved) study drug called Sea-CD70. This study will find out if the drug is safe and tolerable, and find out the maximum tolerated dose (highest dose of a drug or treatment that does not cause unacceptable side effects) or recommended dose for the next phase of clinical study. The subject will be given the study drug in 28 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, ECG (electrocardiogram), or a bone marrow exam. The subject may remain in the study for up to approximately 3 years.

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

Phase 3 trial using the SYK inhibitor, entospletinib, in combination with standard induction and consolidation chemotherapy in newly diagnosed, NPM1-mutated Acute Myelogenous Leukemia

Date Added
February 2nd, 2022
PRO Number
Pro00116455
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects who have been recently diagnosed with AML that is caused by an abnormality in a gene (also called a mutation) called nucleophosmin-1 (NPM-1). The study is testing an "investigational" (not yet FDA approved drug) study drug called Entospletinib. The primary purpose of this study is to to see if a test drug not yet approved (in other words, investigational or not available by prescription), named Entospletinib, can improve the outcome of treatment (in other words, is more effective) in certain people with AML when it is combined with chemotherapy compared with chemotherapy alone, and can be given safely when combined with chemotherapy. MUSC subjects can expect to be in the study for up to approximately 5 years.

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



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