Trial Outcomes & Findings for Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT00492401)

Last Updated: 2016-06-27

Results Overview

Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul. Complete Remission Rate (CRm + CRi)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2016-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Decitabine Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decitabine n=55 Participants Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=113 Participants
Age, Categorical >=65 years	49 Participants n=113 Participants
Sex: Female, Male Female	19 Participants n=113 Participants
Sex: Female, Male Male	36 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants
Race (NIH/OMB) White	55 Participants n=113 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	54 patients n=113 Participants
Region of Enrollment Canada	1 patients n=113 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Outcome measures
Measure	Decitabine n=55 Participants Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days	Non Responder Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
Rate of Complete Remission	25 patients	—

SECONDARY outcome

Timeframe: From baseline to up to day 28 of course 1

Population: Data was not collected and analyzed

Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre treatment

Population: Only pre treatment samples available for testing for 23 patients

Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.

Outcome measures

Outcome measures
Measure	Decitabine n=14 Participants Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days	Non Responder n=9 Participants Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells Expression levels of MiR-29b	0.0056394 delta delta CT values Interval 0.0037495 to 0.0075544	0.0024305 delta delta CT values Interval 0.0014533 to 0.0042197
Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells Expression levels of DNMT3a	0.000196066 delta delta CT values Interval 0.000145407 to 0.000280477	0.000341819 delta delta CT values Interval 0.000289839 to 0.000361753

SECONDARY outcome

Timeframe: From baseline to up to days 28 of course 2

Population: Data was not collected and analyzed for this trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to up to day 28 of course 1

Population: Data was not collected and analyzed for this trial

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Chemotherapy)

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy) n=53 participants at risk Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. decitabine: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies high performance liquid chromatography: Correlative studies microarray analysis: Correlative studies RNA analysis: Correlative studies mass spectrometry: Correlative studies DNA methylation analysis: Correlative studies matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies
Infections and infestations Documented infection	58.5% 31/53 • Number of events 31 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Infections and infestations Febrile neutropenia	9.4% 5/53 • Number of events 5 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
General disorders Fatigue	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
General disorders Fever	3.8% 2/53 • Number of events 2 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Metabolism and nutrition disorders Anorexia	1.9% 1/53 • Number of events 1 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Nervous system disorders Dysgeusia	1.9% 1/53 • Number of events 1 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Gastrointestinal disorders Mucositis/gingivitis	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Respiratory, thoracic and mediastinal disorders Hypoxia	15.1% 8/53 • Number of events 8 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Investigations Prolonged QTc	3.8% 2/53 • Number of events 2 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Cardiac disorders Decreased left ventricular ejection fraction	1.9% 1/53 • Number of events 1 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Gastrointestinal disorders Arrhythmia	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Vascular disorders Hypertension	3.8% 2/53 • Number of events 2 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Skin and subcutaneous tissue disorders Decubitus ulcer	1.9% 1/53 • Number of events 1 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Skin and subcutaneous tissue disorders Rash	3.8% 2/53 • Number of events 2 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Psychiatric disorders Confusion	1.9% 1/53 • Number of events 1 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Nervous system disorders Syncope	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
General disorders Abnormal gait	3.8% 2/53 • Number of events 2 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
General disorders Pain	13.2% 7/53 • Number of events 7 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Vascular disorders Thrombosis	5.7% 3/53 • Number of events 3 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0
Vascular disorders Hemorrhage/hematoma	9.4% 5/53 • Number of events 5 Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0

Additional Information

William Blum, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60