Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00513305
• Other study ID #: C18477/3059/AM/US-CA
• Status: Terminated
• Phase: Phase 3
• First received: August 6, 2007
• Last updated: July 24, 2012
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• The patient has confirmed acute myeloid leukemia (AML).

• The patient is unwilling or unable to tolerate conventional induction chemotherapy.

• The patient has no comorbid conditions that would limit life expectancy to less than 3 months.

• Patient must meet specific laboratory parameters for study inclusion.

Exclusion Criteria:

• The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Previous treatment with low-dose cytarabine is not permitted.

• The patient has a QT interval outside of the protocol-specified range.

• The patient has laboratory values outside of protocol-specified ranges.

• The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.

• The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.

• The patient has known central nervous system involvement with AML.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Arsenic trioxide
Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
• Low-dose cytarabine alone
Cytarabine will be administered at a dose of 10 mg/m^2 subcutaneously (sc) twice a day (bid).

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois	Chicago	Illinois
United States	Brody School of Medicine	Greenville	North Carolina
United States	Indiana Oncology Hematology Consultants	Indianapolis	Indiana
United States	UCLA Medical Center	Los Angeles	California
United States	USC / Norris Cancer Hospital	Los Angeles	California
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	UT Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Complete Remission (CR)	The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.	From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator	No
Secondary	Number of Participants Who Died or Were Censored by 24 Months	This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)	From Baseline through 24 months following Baseline	No
Secondary	Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate	RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.	From Baseline (randomization) through 24 months following Baseline	No
Secondary	Number of Participants Who Experienced Early Death	Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.	14 days from start of study drug treatment	No
Secondary	Number of Participants Who Experienced Induction (Thirty-Day) Mortality	The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.	Up to 30 days following start of study drug treatment	No
Secondary	Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate	The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.	Baseline through 12 months	No