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

NCT02341495 | Terminated Phase 2 Results DMC

• 1 other identifier: 204961
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Azacitidine; Vidaza; Deferasirox; Exjade; Cholecalciferol; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients With Adverse Events

  up to 5 years

• Survival

  up to 5 years

• Duration of Remission

  up to 5 years

Study Arms (1)

Drug Treatment

EXPERIMENTAL

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; Drug: Cholecalciferol; Drug: Azacitidine

Interventions

Deferasirox DRUG

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

Also known as: Exjade

Drug Treatment

Cholecalciferol DRUG

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

Also known as: Vitamin D

Drug Treatment

Azacitidine DRUG

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

Also known as: Vidaza

Drug Treatment

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Henry: lead

Study Sites (1)

Loyola University Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Deferasirox; Cholecalciferol; Vitamin D; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

There are no limitations or caveats to report as the study was terminated early due to low accrual.

Results Point of Contact

• Title: Dr. Elizabeth Henry
• Organization: Loyola University Medical Center

ehenry@lumc.edu

708-327-3153

Study Officials

• Elizabeth Henry, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: January 19, 2015
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)