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

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL) in Adult

Date Added
May 18th, 2023
PRO Number
Pro00128835
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients who have newly diagnosed diagnosed BCR-ABL acute lymphoblastic leukemia (ALL). This study is being done to determine the effects (good or bad) of using the combination of a Tyrosine Kinase Inhibitor (TKI), steroids and blinatumomab versus treatment with steroids, Tyrosine Kinase Inhibitor (TKI) and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Date Added
November 22nd, 2023
PRO Number
Pro00130522
Researcher
Praneeth Baratam

List of Studies

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

This project is being conducted in subjects that have been diagnosed with myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MPN) including chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who are candidates to receive treatment with single agent azacitidine based on local country approvals and/or local The study is designed to move efficiently from Phase 1 to Phase 3. This study is testing investigational drug called ASTX030. Investigational means that it is not approved by the Food and Drug Administration (FDA), but it is undergoing testing to find out if it is safe and effective. ASTX030 is a combination of two medicines, azacitidine and cedazuridine, given by mouth. The primary purpose is to test the levels of the investigational drug ASTX030 in your blood, including if food has an effect (Phase 1B only), the safety and tolerability of the drugs, and how subjects respond to the drug. The subject may remain in the study about 3 years. If you benefit from treatment, you may receive study drugs as long as you continue to benefit. If you develop side effects to the study drugs that prevent you from continuing treatment, or if your study doctor believes it is in your best interest to stop the study drug(s), you may be asked to stop the study treatment. After you stop treatment, the Sponsor will continue to collect health information to evaluate long-term effects of the study drugs.

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929321
HCC-CLINICAL-TRIALS@MUSC.EDU

Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy

Date Added
January 9th, 2024
PRO Number
Pro00128283
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for people newly diagnosed with acute myeloid leukemia (AML). An investigational (not approved by the FDA) drug, Tamibarotene, will be added to the standard of care drugs prescribed. Tamibarotene is a tablet that will be taken daily. The purpose of this study is to determine if the addition of this medication improves the prognosis of these subjects, as this is the first time it has been added to the treatment plan. The most common side effects observed to date include diarrhea, constipation, and vomiting, along with changes in the lab values. Procedures include lab work and bone marrow collections. Participation duration will depend upon how subjects respond to the treatment.

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



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