NCT00850304

Brief Summary

Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 21, 2009

Last Update Submit

February 21, 2009

Conditions

Leukemia, Myeloid, Acute

Keywords

AML

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    1, 2, 6 month and one year after intervention

Secondary Outcomes (1)

  • Overall Survival

    One year after intervention

Study Arms (1)

Arm one

EXPERIMENTAL
Drug: CytosarDrug: Arsenic trioxide

Interventions

CytosarDRUG

Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle

Arm one
Arsenic trioxideDRUG

Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11

Also known as: ATO
Arm one

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly patients with non promyelocytic AML
  • Performance status (ECOG) 3 or 4

You may not qualify if:

  • Age \<60 years
  • Elevation of AST OR ALT more than ten times above normal
  • Serum bilirubin above 5
  • Cr level \> 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology-Oncology and SCT Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CytarabineArsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Kamran Alimoghaddam, M.D.

    Hematology-Oncology and SCT Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2009

First Posted

February 24, 2009

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

IR(1)