A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
- Registration Number
- NCT01034410
- Lead Sponsor
- Antisoma Research
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AS1411-40 AS1411 AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7 AS1411-80 AS1411 AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7 Control Cytarabine cytarabine 2g/m2 bid Days 4-7 AS1411-40 Cytarabine AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7 AS1411-80 Cytarabine AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
- Primary Outcome Measures
Name Time Method 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 Dec 2011
- Secondary Outcome Measures
Name Time Method 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. Dec 2011 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. Dec 2011 To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone. Dec 2011 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. Dec 2011 To further define the PK of AS1411 Dec 2011
Trial Locations
- Locations (14)
UCLA
🇺🇸Los Angeles, California, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Changhua Christian Hospial
🇨🇳Changhua City, Changhua Country, Taiwan
Scroll for more (4 remaining)UCLA🇺🇸Los Angeles, California, United States