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Brief Title: Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML
Official Title: The Clinical Application of Tumor Reversion: A Phase I Study of Sertraline (Zoloft) in Combination With Timed-sequential Cytosine Arabinoside (Ara-C) in Adults With Relapsed and Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT02891278
Brief Summary: This is a Phase I study with the goals of determining the feasibility, safety, and toxicity of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C) in adults with relapsed and refractory acute myeloid leukemia (AML). Primary objective: * To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of sertraline administered in combination with timed-sequential cytosine arabinoside in adult patients with relapsed and refractory acute myeloid leukemia. * To evaluate the safety and tolerability of sertraline given in combination with timed-sequential cytosine arabinoside in adult patients with relapsed and refractory acute myeloid leukemia.
Detailed Description: Relapsed and refractory acute myeloid leukemias are characterized by net drug resistance. At the root of this drug resistance is an enhanced survival that relates to intrinsic cell cycle dysregulation and aberrations in the overall process of the repair of DNA damage. These malignancies represent a continuing therapeutic challenge, since currently no "standard treatments" for these diseases exist. Approximately 30% of adults with newly diagnosed AML are primary refractory to chemotherapy and at least 50% of those who achieve remission will relapse. For patients with relapsed or refractory AML, the expected CR/CRi rates with traditional multi-agent chemotherapies range from \< 10% for primary refractory AML to 25-30% for relapsed AML and cure rates \< 20%, even with allogeneic stem cell transplantation. Thus, novel treatment approaches are needed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Johns Hopkins University Medical Center, Baltimore, Maryland, United States
Columbia University, New York, New York, United States
Name: Daniel Lee, MD
Affiliation: Columbia University
Role: PRINCIPAL_INVESTIGATOR
Name: Joseph Jurcic, MD
Affiliation: Columbia University
Role: PRINCIPAL_INVESTIGATOR