Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide

NCT ID: NCT00850304

Last Updated: 2009-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. Many of this patients are elderly with age further than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard therapy of this patients is high that can reach to 50%. One of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%.

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.

Conditions

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Leukemia, Myeloid, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm one

Group Type EXPERIMENTAL

Cytosar

Intervention Type DRUG

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

Arsenic trioxide

Intervention Type DRUG

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

Interventions

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Cytosar

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

Intervention Type DRUG

Arsenic trioxide

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

Intervention Type DRUG

Other Intervention Names

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ATO

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hematology-Oncology and SCT Research Center

Principal Investigators

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Kamran Alimoghaddam, M.D.

Role: STUDY_DIRECTOR

Hematology-Oncology and SCT Research Center

Locations

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Hematology-Oncology and SCT Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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87-02-36-7242

Identifier Type: -

Identifier Source: org_study_id

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