Maywood, Illinois 60153


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

204961


NCT ID:

NCT02341495


Secondary ID:


Study Acronym:

EXJADE


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

65 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Loyola University


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

29


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Elizabeth Henry, MD
Principal Investigator
Faculty
Primary Contact:Gaye Moran, RN
708-327-3095
gwmoran@lumc.edu
Backup Contact:Ceil Petrowsky, MSN
708-327-3306

Study Dates

Start Date:February 2013
Completion Date:January 2019
Completion Type:Anticipated
Primary Completion Date:January 2018
Primary Completion Type:Anticipated
Verification Date:April 2016
Last Changed Date:April 12, 2016
First Received Date:September 26, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Duration of Remission
Time Frame:up to 5 years
Safety Issues:False
Description:The length of time for remission after achieving complete remission
Outcome Type:Secondary Outcome
Measure:Survival
Time Frame:up to 5 years
Safety Issues:False
Description:The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.
Outcome Type:Secondary Outcome
Measure:Number of patients with adverse events
Time Frame:up to 5 years
Safety Issues:True
Description: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 prob
Outcome Type:Primary Outcome
Measure:Complete Remission rate
Time Frame:up to 5 years
Safety Issues:False
Description: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 i

Study Interventions

Intervention Type:Drug
Name:Deferasirox
Description:Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO
Arm Name:Drug Treatment
Other Name:Exjade
Intervention Type:Drug
Name:Cholecalciferol
Description:Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO
Arm Name:Drug Treatment
Other Name:Vitamin D
Intervention Type:Drug
Name:Azacitidine
Description:Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Arm Name:Drug Treatment
Other Name:Vidaza

Study Arms

Study Arm Type:Experimental
Arm Name:Drug Treatment
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Elizabeth Henry

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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