Trial Outcomes & Findings for Decitabine, Cytarabine, GCSF for Refractory AML/MDS (NCT NCT00740181)

Last Updated: 2022-01-14

Results Overview

Complete Response/Complete Remission: Complete remission (CR) is defined as the presence of all of the following: * Peripheral blood - No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * No Auer rods * Less than 5% blast cells. * CBC and bone marrow criteria must be met within one week of each other. * Hemoglobin 9g/dl or greater * Neutrophil count \>1000 and platelet count \>100,000. * RBC Transfusion free for 2 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

within 30 days of last treatment

Results posted on

2022-01-14

Participant Flow

9 patients were enrolled beginning April 2009 to February 2010

Participant milestones

Participant milestones
Measure	Chemotherapy Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine, Cytarabine, GCSF for Refractory AML/MDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=9 Participants Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	73 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days of last treatment

Outcome measures

Outcome measures
Measure	Chemotherapy n=9 Participants Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Response Rate	1 participants

Adverse Events

Chemotherapy

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=9 participants at risk Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Investigations fever	22.2% 2/9 • Number of events 2 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations death within 30 days treatment- disease related	33.3% 3/9 • Number of events 3 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations dyspnea/penumonitis and bilateral infiltrates , death within 30 days of treatment	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations hemmorrhage-brain, pain-neuro(H/A), weakness	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations infection	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations acute respiratory failure- death not related, neutropenic fever - not related	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations infection, neutropenia	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations fever, infection/pulmonary/upper respiratory (pneumonia)	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations PLT, hemorrhage bladder & CHF/L ventricular systolic dysfunction, infection-pulmonary	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations thrombocytopenia, mucositis, dehydration, dysphagia, syncope, anemia	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations hypoxic respiratory failure and septic shock- possibly related	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations thrombocytopenia, hypoxia, pleural effusion	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)
Investigations syncopal episodes and anemia	11.1% 1/9 • Number of events 1 • Pre-study and prior to each cycle of treatment (on average for 2 cycles, approximately 8-10 weeks)

Other adverse events

Adverse event data not reported

Additional Information

James Butera

Brown Univeristy Oncology Research Group

Phone: 401-863-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place