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

• Sponsor: Antisoma Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00512083
• Collaborator: (none)
• Enrollment: 70
• Locations: 10
• Patients Per Site: 7

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid	Drug: AS1411	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	Univeristy of Colorado Health Cancer Center	Aurora	Colorado	United States	80010
3	St. Francis Hospital and Health Center	Beech Grove	Indiana	United States	46107
4	University of Louisville, James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202
5	Washington University	St Louis	Missouri	United States	63110
6	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
7	Duke University Medical Center	Durham	North Carolina	United States	27710
8	Medical University of South Carolina	Charleston	South Carolina	United States	29425
9	Cancer Therapy and Research Center - Institute for Drug development	San Antonio	Texas	United States	78229
10	Christchurch Hospital	Christchurch		New Zealand

Sponsors and Collaborators

• Antisoma Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00512083
• Other Study ID Numbers: AS1411-C-201
• First Posted: Aug 7, 2007
• Last Update Posted: Sep 25, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Leukemia, Myeloid + Acute Disease
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Sep 25, 2009