NCT02413021

Brief Summary

The purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

January 10, 2015

Last Update Submit

February 24, 2016

Conditions

Acute Myeloid LeukemiaAcute Lymphoid Leukemia

Keywords

Acute Myeloid LeukemiaAcute Lymphoid Leukemiadeferasirox

Outcome Measures

Primary Outcomes (1)

  • complete Remission

    first month

Secondary Outcomes (1)

  • Partial Remission

    up to four weeks

Study Arms (2)

deferasirox + cytarabine

EXPERIMENTAL

deferasirox + cytarabine group will receive oral deferasirox at 20 mg/kg per day and cytarabine at20 mg/m\^2 , SC , two times a day for 10 days every 30 days for 1 cycle.

Drug: CytarabineDrug: Deferasirox

cytarabine

ACTIVE COMPARATOR

cytarabine group will receive just cytarabine at 20 mg/m\^2 , SC , two times a day for 10 days every 30 days for 1 cycle.

Drug: Cytarabine

Interventions

CytarabineDRUG

20 mg/m\^2 , SC, two times a day for 10 days every 30 days for 1 cycle

Also known as: Cytosar
cytarabinedeferasirox + cytarabine
DeferasiroxDRUG

20 mg/kg ,oral, per day

Also known as: osveral
deferasirox + cytarabine

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons:
  • age \> 65
  • existence of another illness, such as heart failure (EF\> 40)
  • \. Ferritin \< 500 μg / l
  • \. Not existence of other co morbidity
  • \. GFR \> 40

You may not qualify if:

  • GFR \< 40
  • Control group become iron overloaded (Ferritin \> 500 μg /l)
  • Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
  • Not willing to continue treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Heath JL, Weiss JM, Lavau CP, Wechsler DS. Iron deprivation in cancer--potential therapeutic implications. Nutrients. 2013 Jul 24;5(8):2836-59. doi: 10.3390/nu5082836.

    PMID: 23887041BACKGROUND

  • Paubelle E, Zylbersztejn F, Alkhaeir S, Suarez F, Callens C, Dussiot M, Isnard F, Rubio MT, Damaj G, Gorin NC, Marolleau JP, Monteiro RC, Moura IC, Hermine O. Deferasirox and vitamin D improves overall survival in elderly patients with acute myeloid leukemia after demethylating agents failure. PLoS One. 2013 Jun 20;8(6):e65998. doi: 10.1371/journal.pone.0065998. Print 2013.

    PMID: 23840388BACKGROUND

  • Fukushima T, Kawabata H, Nakamura T, Iwao H, Nakajima A, Miki M, Sakai T, Sawaki T, Fujita Y, Tanaka M, Masaki Y, Hirose Y, Umehara H. Iron chelation therapy with deferasirox induced complete remission in a patient with chemotherapy-resistant acute monocytic leukemia. Anticancer Res. 2011 May;31(5):1741-4.

    PMID: 21617233BACKGROUND

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CytarabineDeferasirox

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzoles

Study Officials

  • Valiollah Mehrzad, MD

    Seyyed-alshohada hospital of Isfahan

    PRINCIPAL INVESTIGATOR

  • Shaghayegh Haghjoo Javanmard, MD, PHD

    Applied Physiology Research Center

    PRINCIPAL INVESTIGATOR

  • Mahnaz Danesh, MD

    Seyyed-alshohada hospital of Isfahan

    PRINCIPAL INVESTIGATOR

  • Alireza Eishi, Med student

    Applied Physiology Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahnaz Danesh, MD

CONTACT

00983132350210takabgh@yahoo.com

Alireza Eishi, Med student

CONTACT

00983137922295alireza.eishi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 10, 2015

First Posted

April 9, 2015

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

February 25, 2016

Record last verified: 2016-02