Trial Outcomes & Findings for Hematopoietic Stem Cell Support in Vasculitis (NCT NCT00278512)

NCT ID: NCT00278512

Last Updated: 2018-08-02

Results Overview

Survival

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2018-08-02

Participant Flow

Participant milestones

Measure	Autologous Stem Cell Transplant Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning
Overall Study STARTED	7	0
Overall Study COMPLETED	6	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Autologous Stem Cell Transplant Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning
Overall Study Death	1	0

Baseline Characteristics

Hematopoietic Stem Cell Support in Vasculitis

Baseline characteristics by cohort

Measure	Autologous Stem Cell Transplant n=7 Participants Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.43 years STANDARD_DEVIATION 12.03 • n=5 Participants	—	40.43 years STANDARD_DEVIATION 12.03 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	—	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Survival

Outcome measures

Measure	Autologous Stem Cell Transplant n=7 Participants Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning
Survival	6 Participants	0 Participants

Adverse Events

Autologous Stem Cell Transplant

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Allogeneic Stem Cell Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Autologous Stem Cell Transplant n=7 participants at risk Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning
Infections and infestations CMV Hepatitis	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant

Other adverse events

Measure	Autologous Stem Cell Transplant n=7 participants at risk Autologous Stem Cell Transplant will be performed on eligible patients Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning	Allogeneic Stem Cell Transplant Allogeneic Stem Cell Transplant will be performed on eligible patients Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning
Infections and infestations Swine flu	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant
Infections and infestations Aspergillus	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant
Infections and infestations Pseudomonas pneumonia	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant
Gastrointestinal disorders bowel obstruction	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant
Cardiac disorders Pulmonary Embolus	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant
Vascular disorders Deep Vein Thrombosis	14.3% 1/7 • Number of events 1 • 6 months, 1 year, then yearly for at least 5 years post transplant	— 0/0 • 6 months, 1 year, then yearly for at least 5 years post transplant

Additional Information

Dr Richard Burt

Northwestern University

Phone: 312-695-4960

Email: rburt@northwestern.edu

Results disclosure agreements

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