Trial Outcomes & Findings for Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome (NCT NCT00968071)

Results Overview

Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Up to 36 weeks

Results posted on

2013-03-08

Participant Flow

Recruitment Period: 2/19/2008 through 5/12/2009. All participants recruited at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Decitabine + Gemtuzumab Ozogamicin Decitabine 20 mg/m\^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decitabine Gemtuzumab Ozogamicin n=71 Participants Decitabine 20 mg/m\^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
Age Continuous	65 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 weeks

Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.

Outcome measures

Outcome measures
Measure	Decitabine Gemtuzumab Ozogamicin n=71 Participants Decitabine 20 mg/m\^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
Number of Participants With Complete Response (CR)	3 participants

Adverse Events

Decitabine Gemtuzumab Ozogamicin

Serious events: 15 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Decitabine Gemtuzumab Ozogamicin n=71 participants at risk Decitabine 20 mg/m\^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
General disorders Death	21.1% 15/71 • Number of events 15 • Four years, six months

Other adverse events

Other adverse events
Measure	Decitabine Gemtuzumab Ozogamicin n=71 participants at risk Decitabine 20 mg/m\^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
Infections and infestations Infection other	31.0% 22/71 • Number of events 24 • Four years, six months
Infections and infestations Febrile Neutropenia	33.8% 24/71 • Number of events 27 • Four years, six months
Gastrointestinal disorders Hemorrhage	7.0% 5/71 • Number of events 5 • Four years, six months

Additional Information

Gautam Borthakur M.D./Associate Proffesor

The University of Texas M. D. Anderson Cancer Center

Phone: 713-563-1586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place