Trial Outcomes & Findings for Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT) (NCT NCT00231309)

Results Overview

Evaluate the numbers of participants with disease-free survival

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

260 days

Results posted on

2014-08-22

Participant Flow

10 patients were enrolled between July 2003 and March 2006. Patients were enrolled during consent visits for upcoming bone marrow transplants.

Patients were not excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	Granulocyte Colony Stimulating Factor Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=10 Participants Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.47 years STANDARD_DEVIATION 4.78 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 260 days

Evaluate the numbers of participants with disease-free survival

Outcome measures

Outcome measures
Measure	Granulocyte-stimulating Factor n=10 Participants Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
Numbers of Participants With Disease-free Survival.	10 participants

SECONDARY outcome

Timeframe: inpatient hospital stay

hospital length of stay of each patient enrolled, an average of 5 weeks.

Outcome measures

Outcome measures
Measure	Granulocyte-stimulating Factor n=10 Participants Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
Hospital Length of Stay	35 average days Standard Deviation 70

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kuang-Yueh Chiang, MD

Emory University

Phone: 404-785-1441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place