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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AS1411-C-201

NCT ID:

NCT00512083

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Leukemia, Myeloid
  • Leukemia, Myeloid + Acute Disease
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Duke University Medical CenterDurham, North Carolina  27710
UCLA Medical CenterLos Angeles, California  90095-7059
Washington UniversitySt. Louis, Missouri  63110
University of Louisville, James Graham Brown Cancer CenterLouisville, Kentucky  40202
Univeristy of Colorado Health Cancer CenterAurora, Colorado  80010
St. Francis Hospital and Health CenterBeech Grove, Indiana  46107
Cancer Therapy and Research Center - Institute for Drug developmentSan Antonio, Texas  78229