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Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65 (EXJADE)

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ClinicalTrials.gov Identifier: NCT02341495
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth Henry, Loyola University

Brief Summary:
The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia will go into complete remission (meaning the leukemia is completely gone), and to find out how long it stays away. The drugs used in this project are FDA approved and commercially available.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Deferasirox Drug: Cholecalciferol Drug: Azacitidine Phase 2

Detailed Description:
The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard therapies for AML often have significant toxicity and are poorly tolerated by this patient population. Treatment strategies for elderly patients with AML are limited. In those patients who do achieve complete remission, duration of remission tends to be short. Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there is need for safer and more effective therapies for elderly patients with AML. This trial is a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in patients 65 years or older with newly diagnosed AML who are not fit for standard induction chemotherapy or hematopoietic stem-cell transplantation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Examining the Use of Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed Acute Myelogenous Leukemia (AML) in Elderly Patients
Study Start Date : February 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: Drug Treatment
Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV
Drug: Deferasirox
Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO
Other Name: Exjade

Drug: Cholecalciferol
Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO
Other Name: Vitamin D

Drug: Azacitidine
Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Other Name: Vidaza




Primary Outcome Measures :
  1. Complete Remission rate [ Time Frame: up to 5 years ]
    The Complete Remission Rate for all evaluable patients will be reported for the following treatment: azacitadine, vitamin D, and deferasirox (Exjade). The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact confidence interval.


Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 5 years ]
    Characterization of the safety of an induction regimen of azacitadine in combination with vitamin D and deferasirox (Exjade). The proportion of patients experiencing severe adverse events, and the number of patients experiencing severe adverse events probably or definitely related to treatment will be determined. Adverse events will be tabulated by category and graded by NCI CTCAE version 4.0

  2. Survival [ Time Frame: up to 5 years ]
    The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.

  3. Duration of Remission [ Time Frame: up to 5 years ]
    The length of time for remission after achieving complete remission



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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 or older (must have reached 65th birthday)
  • Morphologically confirmed diagnosis of AML, excluding AML-M3
  • Must have a Zubrod performance status of 0-3

Exclusion Criteria:

  • Patients with known HIV infection are excluded. If HIV infection is suspected based on clinical condition, testing may be performed at the discretion of treatment team, but is not mandated prior to enrollment.
  • Patients with central nervous system involvement by AML are excluded
  • Patients with history of an active cancer (except basal cell and squamous cell cancers of the skin) within the previous 2 years are excluded

Information from the National Library of Medicine

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): NCT02341495


Contacts
Contact: Gaye Moran, RN 708-327-3095 gwmoran@lumc.edu
Contact: Ceil Petrowsky, MSN 708-327-3306

Locations
United States, Illinois
Loyola University Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Elizabeth Henry, MD         
Sub-Investigator: Sucha Nand, MD         
Sponsors and Collaborators
Elizabeth Henry
Investigators
Principal Investigator: Elizabeth Henry, MD Faculty

Responsible Party: Elizabeth Henry, Faculty, Loyola University
ClinicalTrials.gov Identifier: NCT02341495     History of Changes
Other Study ID Numbers: 204961
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Elizabeth Henry, Loyola University:
Azacitidine
Vidaza
Deferasirox
Exjade
Cholecalciferol
Vitamin D

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Vitamins
Vitamin D
Cholecalciferol
Azacitidine
Deferasirox
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Iron Chelating Agents
Chelating Agents
Sequestering Agents