Please assess the completion status of the following clinical trial:

Trial Title: Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Age 17- 60 years old at the time of pretransplant evaluation~2. An established diagnosis of scleroderma~3. Diffuse cutaneous scleroderma with involvement proximal to the elbow or knee and a Rodnan score (see Appendix V) of \> 14 AND~   Scleroderma with any one of the following:~  1. DLCO \< 80% of predicted or decrease in lung function (DLCO, DLCO/VA or FVC) of 10% or more over 12 months.~  2. Pulmonary fibrosis or alveolitis on CT scan or chest X-ray (CXR) (ground glass appearance of alveolitis).~  3. Abnormal EKG \[non-specific ST-segment and T-wave (ST-T) (pattern in electrocardiogram) wave abnormalities, low QRS (a pattern seen in an electrocardiogram that indicates the pulses in a heart beat and their duration) voltage, or ventricular hypertrophy\], or pericardial effusion or pericardial enhancement on MRI~  4. Gastrointestinal tract involvement confirmed on radiological study. Radiologic findings of scleroderma are small bowel radiographs showing thickened folds with dilated loops, segmentation, and flocculation +/- diverticula, or pseudodiverticula. A hide-bound appearance due to valvulae packing i.e. dilated and crowded circular folds may be present. GI involvement may also be confirmed by D-xylose malabsorption, patulous esophagus on HRCT, or esophageal manometry.~   OR~4. As published in New England Journal of Medicine (NEJM), 2006, 345:25 2655-2709. Limited or diffuse Systemic Sclerosis with (SSCL) with lung involvement defined as active alveolitis on Bronchoalveolar Lavage (BAL) or ground-glass opacity on CT, a DLCO \< 80% predicted or decrease in lung function (DLCO/VA, DLCO, FVC) of 10% or more in last 12 months.~Exclusion Criteria:~1. Significant end organ damage such as:~   1. Left Ventricular Function (LVEF) \< 40% on echocardiogram.~  2. Untreated life-threatening arrhythmia.~  3. Active ischemic heart disease or heart failure.~  4. End-stage lung disease characterized by TLC\<45% of predicted value, or DLCO hemoglobin corrected \< 30% predicted .~  5. Pulmonary arterial hypertension defined on right heart catheterization as:~      1. a resting Mean Pulmonary Artery Pressure (mPAP) \> 25 mmHg;~     2. a mPAP \> 30 mmHg following a 500-1000 ml normal saline bolus;~     3. pulmonary vascular resistance (PVR) \> 240 dynes\*s/cm5 (\> 3 Wood units) ; or~     4. a decrease in cardiac output with fluid challenge (500 - 1000 cc Normal Saline (NS) in 10 minutes) If fluid challenge cannot be done because right atrial (RA) pressure \> 12mm Hg or pulmonary capillary wedge pressure (PCWP) \> 15 m Hg at rest or must be stopped due to safety concerns, patient is excluded as candidate.~  6. Serum creatinine \> 1.4 mg/dl.~  7. Liver cirrhosis, transaminases \> 3x of normal limits or bilirubin \> 2.0 unless due to Gilbert's disease.~  8. Pericardial effusion \> 1 cm on cardiac MRI unless successful pericardiocentesis has been performed~  9. Occult or clinical constrictive pericarditis~  10. On echocardiogram tricuspid annular peak systolic excursion (TAPSE) ≤ 1.8 cm or, grade II or worse Right Ventricular (RV) or Left Ventricular (LV) diastolic dysfunction~  11. On cardiac MRI, a diastolic septal bounce or diastolic septal flattering (D-sign), or diffuse myocardial gadolinium enhancement, or diffuse hypokinesis (patchy late gadolinium myocardial enhancement are not exclusion criteria)~  12. Ventricular tachycardia (sustained or non-sustained, multifocal or unifocal) on EKG or 24 hour Holter~2. HIV positive.~3. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment.~4. Prior history of malignancy~5. Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.~6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.~7. Inability to give informed consent.~8. Major hematological abnormalities such as platelet count \< 100,000/ul or absolute neutrophil count (ANC) \< 1000/ul.~9. Hepatitis B or C positive

- Gender: ALL
- Minimum Age: 17 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Cyclophosphamide rATG/HSCT (Type: ACTIVE_COMPARATOR): The control arm will have the same conditioning regimen used in ASSIST study. The conditioning regimen will be 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.
- Cyclophosphamide rATG/Fludarabine/HSCT (Type: EXPERIMENTAL): The conditioning regimen will be 120 mg/kg of intravenous cyclophosphamide given in 2 equal fractions on days -3 and -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. PBSC will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy