Systemic Lupus ErythematosusPhase 1NCT00017641
Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
A Phase 1 study testing anti-thymocyte globulin, cyclophosphamide and filgrastim in people with Systemic Lupus Erythematosus, run by Northwestern Memorial Hospital at 2 sites in United States.
Trial summary
OBJECTIVES: I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 0 to 59 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- anti-thymocyte globulin, cyclophosphamide and filgrastim
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2001to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:
- Nephritis (WHO class III or IV)
- Failed NIH short-course cyclophosphamide therapy
- Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure)
- Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following:
Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL
Platelet count less than 40,000/mm3 (without transfusions)
Granulocyte count less than 1,000/mm3
Catastrophic anti-phospholipid syndrome
--Patient Characteristics--
Cardiovascular:
- LVEF at least 35%
- No lupus-induced myocarditis
- No history of unstable angina
Pulmonary:
- FEV1/FVC at least 50% predicted
- DLCO at least 50% predicted
Other:
- HIV negative
- No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer
- No uncontrolled diabetes mellitus
- No medical illness that would preclude study
- No psychiatric illness or mental deficiency that would preclude study
- No known hypersensitivity to E. coli-derived proteins
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
About this study
OBJECTIVES:
- Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.
Read the detailed description
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.
Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- anti-thymocyte globulin, cyclophosphamide, filgrastim, CD34+ Peripheral Blood Stem Cell Reinfusion
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Connective Tissue Diseases, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinDrug
cyclophosphamideDrug
filgrastimDrug
CD34+ Peripheral Blood Stem Cell ReinfusionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2001 (estimated)
- Study startApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Northwestern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ann Traynor, Study chair, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017641
- Sponsor's protocol ID
- 199/14976
- Other IDs
- NU-95LU1
- Status last verified
- Nov 2003
- First submitted
- 6 Jun 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00017641
- Acronym / sponsor ID
- 199/14976
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Northwestern Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2001
- First posted
- 6 Jun 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.
Detailed description
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.
Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulin | Drug | – |
| cyclophosphamide | Drug | – |
| filgrastim | Drug | – |
| CD34+ Peripheral Blood Stem Cell Reinfusion | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Traynor study chair
Northwestern Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-thymocyte globulin, cyclophosphamide and filgrastim in people with Systemic Lupus Erythematosus, run by Northwestern Memorial Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.