Trial Outcomes & Findings for Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS) (NCT NCT00882102)

Results Overview

Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Day 14 of first cycle

Results posted on

2013-09-13

Participant Flow

Recruitment Period: 04/02/09 through 6/23/2010. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.

Of the forty-three participants registered only forty participants received treatment and were evaluable for toxicity and response.

Participant milestones

Participant milestones
Measure	Decitabine + Gemtuzumab Ozogamicin Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decitabine + Gemtuzumab Ozogamicin n=40 Participants Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Age Continuous	74 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 of first cycle

Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).

Outcome measures

Outcome measures
Measure	Decitabine + Gemtuzumab Ozogamicin n=40 Participants Decitabine 20 mg/m\^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m\^2 by vein on day 5.
Number of Participants With a Complete Response	10 Participants

Adverse Events

Decitabine + Gemtuzumab Ozogamicin

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Decitabine + Gemtuzumab Ozogamicin n=40 participants at risk Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Metabolism and nutrition disorders Elevated Amylase/Lipase	2.5% 1/40 • Number of events 1 • Three years, four months.

Other adverse events

Other adverse events
Measure	Decitabine + Gemtuzumab Ozogamicin n=40 participants at risk Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Gastrointestinal disorders Hemorhage	5.0% 2/40 • Number of events 2 • Three years, four months.
Infections and infestations Febrile Neutropenia	50.0% 20/40 • Number of events 20 • Three years, four months.
Infections and infestations Infection	10.0% 4/40 • Number of events 4 • Three years, four months.
Gastrointestinal disorders Mucositis	5.0% 2/40 • Number of events 2 • Three years, four months.

Additional Information

Gautam Borthakur, MD/Associate Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-563-1586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place