Trial Outcomes & Findings for Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) (NCT NCT00684255)

NCT ID: NCT00684255

Last Updated: 2014-04-01

Results Overview

Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 1 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2014-04-01

Participant Flow

Study closed due to low accrual.

Participant milestones

Measure	Reduced Intensity Regimen SSc Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

Baseline characteristics by cohort

Measure	Systemic Sclerosis (SSc) n=1 Participants Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Probability of progression free and overall survival will be measured.

Outcome measures

Outcome data not reported

Adverse Events

Reduced Intensity Regimen SSc

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

Dr. Mitchell S. Cairo

New York Medical College

Phone: 914-594-3650

Email: mitchell_cairo@nymc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place