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Phase II Study of AS1411 Comb...

Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

NCT ID: NCT00512083

Last Updated: 2009-09-25

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

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Detailed Description

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Conditions

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Leukemia, Myeloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AS1411

AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary refractory or relapsed AML
* confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
* aged at least 18 years

Exclusion Criteria

* initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
* patient in blast crisis stage of chronic myeloid leukemia
* received high-dose cytarabine (total cumulative dose of \>6g/m sq)in last 6 months
* interval of \<6 months between first onset of last complete remission and current relapse
* those with primary refractory leukemia who have received more than three previous induction cycles
* relapsed patients who have received more than three previous treatment regimens

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers