FindMyKOL
Clinical trialNCT01413100CompletedPhase 2Interventional

Scleroderma Treatment With Autologous Transplant (STAT) Study

SponsorFred Hutchinson Cancer CenterEnrollment21Systemic Scleroderma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stored prior to treatment. To store the stem cells patients are given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be collected and stored. After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for the transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells have "engrafted" and have matured enough to support the immune system at approximately 2-3 months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or reactivation of SSc and is referred to as maintenance therapy.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Leona Holmberg

    Fred Hutch/University of Washington Cancer Consortium

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

  • Ucla / Jonsson Comprehensive Cancer Center

    Los Angeles, California, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, United States

  • University of Colorado

    Denver, Colorado, United States

  • Boston Medical Center

    Boston, Massachusetts, United States

  • Boston University School of Medicine

    Boston, Massachusetts, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • M D Anderson Cancer Center

    Houston, Texas, United States

  • the University of Texas Health Science Center, Houston

    Houston, Texas, United States

  • Fred Hutch/university of Washington Cancer Consortium

    Seattle, Washington, United States

  • Seattle Children'S Hospital

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Sept 2011
Primary completion
15 Sept 2023
Completion
11 Sept 2024
Last update posted
7 Jan 2025
Registered enrollment
21
Registry id
NCT01413100

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.