Trial Outcomes & Findings for Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus (NCT NCT00278538)

NCT ID: NCT00278538

Last Updated: 2020-02-28

Results Overview

The primary efficacy outcome is overall survival.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: 6 months, then yearly x 5 years after transplant
• Results posted on: 2020-02-28

Participant Flow

Participant milestones

Measure	Hematopoietic Stem Cell Transplantation Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Measure	Hematopoietic Stem Cell Transplantation n=32 Participants Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months, then yearly x 5 years after transplant

Population: The # analyzed at 6 mos.- 4 years differs from the overall participant # analyzed because 2 participants were declined HSCT due to comorbidities and 2 died within 6 mos. after HSCT unrelated to the treatment. The # analyzed at 5 years differs from the overall participants analyzed due to an unrelated treatment death at 4 years after HSCT. .

The primary efficacy outcome is overall survival.

Outcome measures

Measure	Hematopoietic Stem Cell Transplantation n=30 Participants Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Survival 6 Month Post Transplant Survival · Total Participant Survival	28 Participants
Survival 6 Month Post Transplant Survival · Non Treatment Related Death	2 Participants
Survival 1 Year Post Transplant Survival · Total Participant Survival	28 Participants
Survival 4 Year Post Transplant Survival · Non Treatment Related Death	1 Participants
Survival 1 Year Post Transplant Survival · Non Treatment Related Death	0 Participants
Survival 2 Year Post Transplant Survival · Total Participant Survival	28 Participants
Survival 2 Year Post Transplant Survival · Non Treatment Related Death	0 Participants
Survival 3 Year Post Transplant Survival · Total Participant Survival	28 Participants
Survival 3 Year Post Transplant Survival · Non Treatment Related Death	0 Participants
Survival 4 Year Post Transplant Survival · Total Participant Survival	27 Participants
Survival 5 Year Post Transplant Survival · Total Participant Survival	27 Participants
Survival 5 Year Post Transplant Survival · Non Treatment Related Death	0 Participants

Adverse Events

Hematopoietic Stem Cell Transplantation

Serious events: 5 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Measure	Hematopoietic Stem Cell Transplantation n=30 participants at risk Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Cardiac disorders Elevated Troponin	3.3% 1/30 • Number of events 1 • 5 year
Metabolism and nutrition disorders Hypokalemia	10.0% 3/30 • Number of events 3 • 5 year
General disorders Intracranial Hemorrhage	3.3% 1/30 • Number of events 1 • 5 year

Other adverse events

Measure	Hematopoietic Stem Cell Transplantation n=30 participants at risk Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Infections and infestations Neutropenic Fevers	33.3% 10/30 • Number of events 10 • 5 year
Metabolism and nutrition disorders Hypokalemia	26.7% 8/30 • Number of events 8 • 5 year
Cardiac disorders Hypertension	23.3% 7/30 • Number of events 7 • 5 year
Metabolism and nutrition disorders Hyperglycemia	20.0% 6/30 • Number of events 6 • 5 year
Metabolism and nutrition disorders Hypophosphatemia	16.7% 5/30 • Number of events 5 • 5 year
General disorders Dyspnea	16.7% 5/30 • Number of events 5 • 5 year
Metabolism and nutrition disorders Hypomagnesemia	10.0% 3/30 • Number of events 3 • 5 year
Metabolism and nutrition disorders Hypocalcemia	10.0% 3/30 • Number of events 3 • 5 year
General disorders Elevated Transaminase	6.7% 2/30 • Number of events 2 • 5 year
Cardiac disorders Chest Pain	6.7% 2/30 • Number of events 2 • 5 year

Additional Information

Kathleen Quigley

Northwestern University

Phone: 312-695-8192

Email: k-quigley@northwestern.edu

Results disclosure agreements

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