Trial Outcomes & Findings for Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies (NCT NCT00689884)

Results Overview

Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

2 years

Results posted on

2018-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy Plus Pegfilgrastim All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy Plus Pegfilgrastim n=7 Participants All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	60 years STANDARD_DEVIATION 22 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each stage of pheresis for each enrolled subject for a maximum of 2 years.

Population: Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy Plus Pegfilgrastim

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

John M. Hill, MD - Principal Investigator

Dartmouth-Hitchcock Medical Center

Phone: 603-650-4628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place