Trial Outcomes & Findings for Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft (NCT NCT00814983)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

One year from date of transplant

Results posted on

2013-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Stem Cell Transplant No Manipulation Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation	Naive T-cell Depleted Stem Cell Transplant Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
Overall Study STARTED	15	0
Overall Study COMPLETED	12	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stem Cell Transplant No Manipulation Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation	Naive T-cell Depleted Stem Cell Transplant Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
Overall Study Screen failure	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Graft failure	1	0

Baseline Characteristics

Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Transplant No Manipulation n=15 Participants Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation	Naive T-cell Depleted Stem Cell Transplant Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.	Total n=15 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	15 participants n=5 Participants	—	15 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	8 participants n=5 Participants	—	8 participants n=5 Participants
Gender Male	7 participants n=5 Participants	—	7 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	—	15 participants n=5 Participants

PRIMARY outcome

Timeframe: One year from date of transplant

Population: No analysis was performed since the experimental arm was not opened

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: No analysis was performed since the experimental arm was not opened

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: No analysis was performed since the experimental arm was not opened

The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.

Outcome measures

Outcome data not reported

Adverse Events

Stem Cell Transplant No Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naive T-cell Depleted Stem Cell Transplant

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

Mitchell Horwitz, MD

Duke University Medical Center

Phone: 919-668-1045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place