Trial Outcomes & Findings for Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia (NCT NCT00509600)

NCT ID: NCT00509600

Last Updated: 2012-08-07

Results Overview

Response is defined as a WBC \< 15,000 and platelets \> 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2012-08-07

Participant Flow

Recruitment Period: 05/19/04 through 03/05/09. All participants recruited at UT MD Anderson Cancer Center.

Study was terminated due to low accrual.

Participant milestones

Measure	Etanercept 0.8 mg/kg subcutaneously weekly for 90 days
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Etanercept 0.8 mg/kg subcutaneously weekly for 90 days
Overall Study Adverse Event	1

Baseline Characteristics

Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

Baseline characteristics by cohort

Measure	Etanercept n=1 Participants 0.8 mg/kg subcutaneously weekly for 90 days
Age Continuous	3 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.

Response is defined as a WBC < 15,000 and platelets > 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Etanercept

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept n=1 participants at risk 0.8 mg/kg subcutaneously weekly for 90 days
General disorders Toxicity	100.0% 1/1 • Number of events 1 • Study period 4 years and 10 months. Only patient registered on study for two (2) months.

Other adverse events

Adverse event data not reported

Additional Information

Robert J. Wells, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-792-6620

Results disclosure agreements

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