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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO

Cholecalciferol

Intervention Type DRUG

Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO

Azacitidine

Intervention Type DRUG

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

Interventions

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Deferasirox

Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO

Intervention Type DRUG

Cholecalciferol

Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO

Intervention Type DRUG

Azacitidine

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

Intervention Type DRUG

Other Intervention Names

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Exjade Vitamin D Vidaza

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No