Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML
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|ClinicalTrials.gov Identifier: NCT02891278|
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : March 10, 2020
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).
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Sertraline Drug: Cytosine arabinoside Procedure: allogeneic stem cell transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||August 11, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Sertraline with cytosine arabinoside
All subjects will receive the following:
Patients who achieve complete remission (CR) or complete remission with incomplete count recovery (CRi) and are eligible for allogeneic stem cell transplantation will receive one of the following:
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.
Other Name: Zoloft
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.
Other Name: allogeneic SCT
- Maximum Tolerated Dose (MTD) of sertraline administered in combination with timed-sequential cytosine arabinoside [ Time Frame: Up to 24 months ]Standard 3+3 dose-escalation design will be used to determine the MTD. The MTD will be determined as the highest dose level where 1/6 patients experience dose-limiting toxicity (DLT). Three patients will be treated at a given dose level combination and observed for at least 4 weeks to assess toxicity. Doses will not be escalated in any individual patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891278
|Contact: Lisa Olmos, RNemail@example.com|
|Contact: Ryan Shelton, BSfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Ivana Gojo 410-502-7726 email@example.com|
|Principal Investigator: Ivana Gojo, MD|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Maria Katsigeorgis, MS firstname.lastname@example.org|
|Contact: Ryan Shelton, BS email@example.com|
|Sub-Investigator: Mark Frattini, MD|
|Principal Investigator: Daniel J Lee, MD|
|Principal Investigator:||Daniel Lee, MD||Columbia University|