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OpenTrials
Completed

NCT Number: NCT00512083

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

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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Key information

Conditions

Leukemia, Myeloid Acute Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Christchurch Hospital, Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AS1411

Drug

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

Primary outcomes

  1. The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group

Sponsors and collaborators

Lead sponsor

Antisoma Research

Industry

Registry information

Official study title

An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Important dates

Study start
2007
Primary completion
2009
First posted
Aug 7, 2007
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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