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Trial Outcomes & Findings for Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML) (NCT NCT00398983)

NCT ID: NCT00398983

Last Updated: 2013-03-04

Results Overview

Relapse free response defined an absence of relapse at one year of follow up.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Baseline to 1 year

Results posted on

2013-03-04

Participant Flow

Recruitment Period: 8/28/2006 to 10/15/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Of the fifty participants registered, forty-five participants were evaluable. Twenty were randomized to Decitabine 20 mg/m\^2, and twenty-five were randomized to no study drug. Five participants withdrew consent or developed complications before assignment of treatment.

Participant milestones

Participant milestones
Measure
Decitabine 20 mg/m^2
20 mg/m\^2 intravenous (IV) daily for 5 days
No Study Drug
Continue current therapy.
Overall Study
STARTED
20
25
Overall Study
COMPLETED
20
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Decitabine 20 mg/m^2
n=20 Participants
20 mg/m\^2 intravenous (IV) daily for 5 days
No Study Drug
n=25 Participants
Continue current therapy.
Total
n=45 Participants
Total of all reporting groups
Age Continuous
62 years
n=5 Participants
53 years
n=7 Participants
57 years
n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
12 Participants
n=7 Participants
26 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
13 Participants
n=7 Participants
19 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
25 participants
n=7 Participants
45 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1 year

Relapse free response defined an absence of relapse at one year of follow up.

Outcome measures

Outcome measures
Measure
Decitabine 20 mg/m^2
n=20 Participants
20 mg/m\^2 intravenous (IV) daily for 5 days
No Study Drug
n=25 Participants
Continue current therapy.
Number of Participants With Relapse-Free Response at 1 Year
10 participants
10 participants

Adverse Events

Decitabine 20 mg/m^2

Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths

No Study Drug

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Decitabine 20 mg/m^2
n=20 participants at risk
20 mg/m\^2 intravenous (IV) daily for 5 days
No Study Drug
n=25 participants at risk
Continue current therapy.
Cardiac disorders
Hypertension
5.0%
1/20 • Number of events 1 • Five years, eight months.
0.00%
0/25 • Five years, eight months.
General disorders
Death
5.0%
1/20 • Number of events 1 • Five years, eight months.
0.00%
0/25 • Five years, eight months.

Other adverse events

Other adverse events
Measure
Decitabine 20 mg/m^2
n=20 participants at risk
20 mg/m\^2 intravenous (IV) daily for 5 days
No Study Drug
n=25 participants at risk
Continue current therapy.
Blood and lymphatic system disorders
Neutropenia
95.0%
19/20 • Number of events 19 • Five years, eight months.
16.0%
4/25 • Number of events 4 • Five years, eight months.
Blood and lymphatic system disorders
Thrombocytopenia
70.0%
14/20 • Number of events 14 • Five years, eight months.
12.0%
3/25 • Number of events 3 • Five years, eight months.
Blood and lymphatic system disorders
Anemia
5.0%
1/20 • Number of events 1 • Five years, eight months.
4.0%
1/25 • Number of events 1 • Five years, eight months.
Infections and infestations
Infection
15.0%
3/20 • Number of events 3 • Five years, eight months.
12.0%
3/25 • Number of events 3 • Five years, eight months.
Cardiac disorders
Hypertension
5.0%
1/20 • Number of events 1 • Five years, eight months.
0.00%
0/25 • Five years, eight months.
General disorders
Fatigue
5.0%
1/20 • Number of events 1 • Five years, eight months.
4.0%
1/25 • Number of events 1 • Five years, eight months.

Additional Information

Farhad Ravandi-Kashani, MD / Associate Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-745-0394

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place