Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 11, 2016

Primary Completion Date

November 17, 2020

Study Completion Date

November 17, 2020

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Sertraline

"Sertraline is a selective serotonin reuptake inhibitor (SSRI) that is FDA approved to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder.~Sertraline will be administered orally twice a day starting on day -3. Sertraline will be administered at one of 4 pre-defined dose levels in the following dose-escalation: 50 mg daily, 50 mg twice a day, 50 mg every morning (QAM) and 100 mg every evening (QPM), 100 mg twice a day. 100 mg QAM and 150 mg QPM."

DRUG

Cytosine arabinoside

"Cytarabine is a cytotoxic chemotherapy approved for use in acute myeloid leukemia, acute lymphoblastic leukemia, and chronic myelogenous leukemia. It is also approved to prevent and treat meningeal leukemia. Cytarabine kills cells in S-phase through inhibition of DNA polymerase, as well as by halting DNA synthesis after its incorporation into DNA.~Cytosine arabinoside (Ara-C) will be administered as a 72 hour intravenous continuous infusion (IVCI) beginning Day 1 of therapy and again beginning Day 10 of therapy. The total dose of ara-C for each 72 hour period is 2 gm/m2 (0.667 gm/m2/24 hours)."

PROCEDURE

allogeneic stem cell transplantation

Allogeneic stem cell transplantation involves transferring the stem cells from a healthy person (the donor) to a patient after high-intensity chemotherapy or radiation.

Trial Locations (2)

10032

Columbia University, New York

21287

Johns Hopkins University Medical Center, Baltimore

All Listed Sponsors
collaborator

The Leukemia and Lymphoma Society

OTHER

lead

Columbia University

OTHER

NCT02891278 - Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML | Biotech Hunter | Biotech Hunter