Trial Outcomes & Findings for Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation (NCT NCT00363467)

Results Overview

100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

100 days post transplant

Results posted on

2017-03-23

Participant Flow

Recruitment period May 15, 2006 through May 20, 2009; H. Lee Moffitt Cancer Center.

The study did not involve a wash-out period or group assignment.

Participant milestones

Participant milestones
Measure	Autologous Hematopoietic Progenitor Cell Transplantation G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Hematopoietic Progenitor Cell Transplantation G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Overall Study Physician Decision	1

Baseline Characteristics

Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=3 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Age, Continuous	64 years STANDARD_DEVIATION 2.828427 • n=5 Participants
Age, Customized Between 18 and 65 years	2 participants n=5 Participants
Age, Customized >=65 years	1 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days post transplant

Population: Analysis was "per protocol"

100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease

Outcome measures

Outcome measures
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=2 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
100-day Non-relapse Mortality	0 participants

SECONDARY outcome

Timeframe: At time of stem cell collection

Population: per protocol

Number of subjects who were able to collect at least 2 million CD34+ cells/kg

Outcome measures

Outcome measures
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=2 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Successful Autologous Stem Cell Collection	2 participants

SECONDARY outcome

Timeframe: up to 100 days post translant

Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.

Outcome measures

Outcome measures
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=2 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Severe Regimen-related Toxicity	2 participants

SECONDARY outcome

Timeframe: 1 year post transplant

Number of participants alive and without disease relapse at 1 year posttransplant

Outcome measures

Outcome measures
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=2 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1 Year Event-free Survival	2 participants

SECONDARY outcome

Timeframe: 1 year post transplant

Number of participants alive at 1 year posttransplant

Outcome measures

Outcome measures
Measure	Autologous Hematopoietic Progenitor Cell Transplantation n=2 Participants G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1 Year Overall Survival	2 participants

Adverse Events

Autologous Hematopoietic Progenitor Cell Transplantation

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

Jeffrey Lancet MD

H. Lee Moffitt Cancer Center

Phone: 813-745-6841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place