A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia - Full Text View

Purpose

This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: AS1411 Drug: Cytarabine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine

U.S. FDA Resources

Further study details as provided by Antisoma Research:

Primary Outcome Measures:

To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone. [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]
To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone. [ Time Frame: Dec 2011 ] [ Designated as safety issue: Yes ]
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone. [ Time Frame: Dec 2011 ] [ Designated as safety issue: Yes ]
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone. [ Time Frame: Dec 2011 ] [ Designated as safety issue: Yes ]
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone. [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]
To further define the PK of AS1411 [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2010
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control cytarabine 2g/m2 bid Days 4-7	Drug: Cytarabine Cytarabine 2g/m2 bid Days 4-7 Other Name: Ara-C
Experimental: AS1411-40 AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7	Drug: AS1411 AS1411 40mg/kg/day or AS1411 80mg/kg/day Drug: Cytarabine Cytarabine 2g/m2 bid Days 4-7 Other Name: Ara-C
Experimental: AS1411-80 AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7	Drug: AS1411 AS1411 40mg/kg/day or AS1411 80mg/kg/day Drug: Cytarabine Cytarabine 2g/m2 bid Days 4-7 Other Name: Ara-C

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
ECOG Performance status 0, 1 or 2
Age > 18 and < 70 years
For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow assessment

Exclusion Criteria:

An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
Clinically active CNS leukemia
Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034410

Locations

United States, California
UCLA
Los Angeles, California, United States, 90095
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Taiwan
Changhua Christian Hospial
Changhua City, Changhua Country, Taiwan, 500
China Medical University Hospital
Taichung City, Taiwan, 40447
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei City, Taiwan, 114

Sponsors and Collaborators

Antisoma Research

Investigators

Principal Investigator:

Rob Stuart, MD

MUSC

More Information

No publications provided

Responsible Party:	Fredrik Erlandsson, MD, Antisoma
ClinicalTrials.gov Identifier:	NCT01034410 History of Changes
Other Study ID Numbers:	AS1411-C-203
Study First Received:	December 16, 2009
Last Updated:	February 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Antisoma Research:

AS1411
AML
relapsed

refractory
aptamer
nucleolin

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013