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

Acute Myeloid Leukemia Clinical Trial

— EXJADE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341495
• Other study ID #: 204961
• Status: Terminated
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2020
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia

Intervention

Drug:
• Deferasirox
Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO
• Cholecalciferol
Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO
• Azacitidine
Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks

Locations

Country	Name	City	State
United States	Loyola University Cardinal Bernardin Cancer Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Henry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate	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.	up to 5 years
Secondary	Number of Patients With Adverse Events	Characterization of the safety of an induction regimen of azacitidine 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	up to 5 years
Secondary	Survival	The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.	up to 5 years
Secondary	Duration of Remission	The length of time for remission after achieving complete remission	up to 5 years