Trial Outcomes & Findings for Tissue Repair in Stem Cell Transplant Recipients (NCT NCT00501228)

Results Overview

In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Baseline + 8 Weeks post transplant

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 06/15/2005 through 05/03/2006. All participants enrolled at U.T. M.D. Anderson Cancer Center.

Study terminated early due to lack of accrual.

Participant milestones

Participant milestones
Measure	Filgrastim Injections
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgrastim Injections
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Tissue Repair in Stem Cell Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgrastim Injections n=2 Participants
Age Continuous	48 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline + 8 Weeks post transplant

Population: No analysis was done. Only one eligible patient was able to complete treatment.

In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.

Outcome measures

Outcome data not reported

Adverse Events

Filgrastim Injections

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

Martin Korbling, MD / Professor

U.T. M.D. Anderson Cancer Center

Phone: 713-745-3219

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place