Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

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Detailed Description

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This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Conditions

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Systemic Lupus Erythematosus Systemic Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced Intensity Regimen for Refractory SLE

RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE).

Group Type EXPERIMENTAL

Reduced Intensity Allogeneic Transplant

Intervention Type PROCEDURE

Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).

Fludarabine

Intervention Type DRUG

Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2

Busulfan

Intervention Type DRUG

Busulfan 3.2 mg/kg Days \_8, -7, -6, -5

Campath

Intervention Type DRUG

Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Reduced Intensity Regimen for SSc

RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).

Group Type EXPERIMENTAL

Reduced Intensity Allogeneic Transplant

Intervention Type PROCEDURE

Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).

Fludarabine

Intervention Type DRUG

Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2

Busulfan

Intervention Type DRUG

Busulfan 3.2 mg/kg Days \_8, -7, -6, -5

Campath

Intervention Type DRUG

Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Interventions

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Reduced Intensity Allogeneic Transplant

Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).

Intervention Type PROCEDURE

Fludarabine

Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2

Intervention Type DRUG

Busulfan

Busulfan 3.2 mg/kg Days \_8, -7, -6, -5

Intervention Type DRUG

Campath

Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Intervention Type DRUG

Other Intervention Names

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Alemtuzumab

Eligibility Criteria

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Inclusion Criteria

* Diffuse Systemic Sclerosis and variants as per ACR criteria
* Medically refractory disease
* Adequate Organ Function - Pulmonary function
* Renal function, Cardiac function defined as:
* SGOT (AST) or SGPT (ALT) \<5 x upper limit of normal
* Diagnosis of SLE - Medically refractory disease