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

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ClinicalTrials.gov Identifier: NCT00278538

Recruitment Status : Completed

First Posted : January 18, 2006

Results First Posted : February 28, 2020

Last Update Posted : February 28, 2020

Sponsor:

Information provided by (Responsible Party):

Richard Burt, MD, Northwestern University

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Systemic Lupus Erythematosus
Intervention	Biological: Hematopoietic stem cell transplantation
Enrollment	32

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Hematopoietic Stem Cell Transplantation
Arm/Group Description	Autologous hematopoietic stem cell ...
Arm/Group Description	Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Period Title: Overall Study
Started	32
Completed	30
Not Completed	2

Baseline Characteristics

Arm/Group Title		Hematopoietic Stem Cell Transplantation
Arm/Group Description		Autologous hematopoietic stem cell ...
Arm/Group Description		Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Overall Number of Baseline Participants		32
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	32 100.0%
	>=65 years	0 0.0%
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	32 participants
		32 (16 to 60)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	Female	30 93.8%
	Male	2 6.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	Hispanic or Latino	6 18.8%
	Not Hispanic or Latino	26 81.3%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	32 participants
United States		32

Outcome Measures

1.Primary Outcome


Title	Survival
Description	The primary efficacy outcome is overall survival.
Description	The primary efficacy outcome is overall survival.
Time Frame	6 months, then yearly x 5 years after transplant

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title		Hematopoietic Stem Cell Transplantation
Arm/Group Description:		Autologous hematopoietic stem cell ...
Arm/Group Description:		Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
Overall Number of Participants Analyzed		30
Measure Type: Count of Participants Unit of Measure: Participants
6 Month Post Transplant Survival	Number Analyzed	30 participants
	Total Participant Survival	28 93.3%
	Non Treatment Related Death	2 6.7%
1 Year Post Transplant Survival	Number Analyzed	28 participants
	Total Participant Survival	28 100.0%
	Non Treatment Related Death	0 0.0%
2 Year Post Transplant Survival	Number Analyzed	28 participants
	Total Participant Survival	28 100.0%
	Non Treatment Related Death	0 0.0%
3 Year Post Transplant Survival	Number Analyzed	28 participants
	Total Participant Survival	28 100.0%
	Non Treatment Related Death	0 0.0%
4 Year Post Transplant Survival	Number Analyzed	28 participants
	Total Participant Survival	27 96.4%
	Non Treatment Related Death	1 3.6%
5 Year Post Transplant Survival	Number Analyzed	27 participants
	Total Participant Survival	27 100.0%
	Non Treatment Related Death	0 0.0%

Adverse Events

Time Frame	5 year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Hematopoietic Stem Cell Transplantation
Arm/Group Description	Autologous hematopoietic stem cell ...
Arm/Group Description	Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation
All-Cause Mortality
	Hematopoietic Stem Cell Transplantation
	Affected / at Risk (%)
Total	3/30 (10.00%)
Serious Adverse Events Serious Adverse Events
	Hematopoietic Stem Cell Transplantation
	Affected / at Risk (%)	# Events
Total	5/30 (16.67%)
Cardiac disorders
Elevated Troponin ^† [1]	1/30 (3.33%)	1
General disorders
Intracranial Hemorrhage ^† [1]	1/30 (3.33%)	1
Metabolism and nutrition disorders
Hypokalemia ^† [1]	3/30 (10.00%)	3
† Indicates events were collected by systematic assessment [1] Grade 4 Toxicity During HSCT Hospitalization
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Hematopoietic Stem Cell Transplantation
	Affected / at Risk (%)	# Events
Total	10/30 (33.33%)
Cardiac disorders
Hypertension ^† [1]	7/30 (23.33%)	7
Chest Pain ^† [1]	2/30 (6.67%)	2
General disorders
Dyspnea ^† [1]	5/30 (16.67%)	5
Elevated Transaminase ^† [1]	2/30 (6.67%)	2
Infections and infestations
Neutropenic Fevers ^† [1]	10/30 (33.33%)	10
Metabolism and nutrition disorders
Hypokalemia ^† [1]	8/30 (26.67%)	8
Hyperglycemia ^† [1]	6/30 (20.00%)	6
Hypophosphatemia ^† [1]	5/30 (16.67%)	5
Hypomagnesemia ^† [1]	3/30 (10.00%)	3
Hypocalcemia ^† [1]	3/30 (10.00%)	3
† Indicates events were collected by systematic assessment [1] Grade 3 Toxicity During HSCT Hospitalization

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Kathleen Quigley
Organization:	Northwestern University
Phone:	312-695-8192
EMail:	k-quigley@northwestern.edu

Publications:

Burt RK, Han X, Gozdziak P, Yaung K, Morgan A, Clendenan AM, Henry J, Calvario MA, Datta SK, Helenowski I, Schroeder J. Five year follow-up after autologous peripheral blood hematopoietic stem cell transplantation for refractory, chronic, corticosteroid-dependent systemic lupus erythematosus: effect of conditioning regimen on outcome. Bone Marrow Transplant. 2018 Jun;53(6):692-700. doi: 10.1038/s41409-018-0173-x. Epub 2018 May 31.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burt RK, Craig RM, Milanetti F, Quigley K, Gozdziak P, Bucha J, Testori A, Halverson A, Verda L, de Villiers WJ, Jovanovic B, Oyama Y. Autologous nonmyeloablative hematopoietic stem cell transplantation in patients with severe anti-TNF refractory Crohn disease: long-term follow-up. Blood. 2010 Dec 23;116(26):6123-32. doi: 10.1182/blood-2010-06-292391. Epub 2010 Sep 13.

Layout table for additonal information

Responsible Party:	Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00278538
Other Study ID Numbers:	DI SLE.Auto2003
First Submitted:	January 15, 2006
First Posted:	January 18, 2006
Results First Submitted:	November 18, 2019
Results First Posted:	February 28, 2020
Last Update Posted:	February 28, 2020

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