Phase I Study of Immune Ablation and CD34+ Peripheral Blo... | NCT00017641

ID	Type	Description	Link
NU-95LU1

Status Module

Record Verification Date

Nov 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 6, 2001

First Submission Date that Met QC Criteria

Jun 5, 2001

First Posted Date

Jun 6, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

59 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ann Traynor	Northwestern Memorial Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Memorial Hospital		Chicago	Illinois	60611	United States
University of Wisconsin Hospital and Clinics

ID	Term
D008180	Lupus Erythematosus, Systemic
D001168	Arthritis
D003240	Connective Tissue Diseases
D007154	Immune System Diseases
D003141	Communicable Diseases
D035583	Rare Diseases

ID	Term
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000961	Antilymphocyte Serum
D003520	Cyclophosphamide
D000069585	Filgrastim

Ancestor Terms

ID	Term
D007106	Immune Sera
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D001688	Biological Products
D045424	Complex Mixtures
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D001685	Biological Factors

Name	Type	Description	Arm Group Labels	Other Names
anti-thymocyte globulin	Drug
cyclophosphamide	Drug
filgrastim	Drug
CD34+ Peripheral Blood Stem Cell Reinfusion	Procedure