Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study ID
NCT01047072
Phase
PHASE2
Status
Withdrawn

Conditions

  • Systemic Scleroderma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • fludarabine phosphate — DRUG
    Given IV
  • total-body irradiation — RADIATION
    Undergo total-body irradiation
  • tacrolimus — DRUG
    Given orally
  • mycophenolate mofetil — DRUG
    Given orally
  • rituximab — BIOLOGICAL
    Given IV
  • cyclophosphamide — DRUG
    Given orally
  • nonmyeloablative allogeneic hematopoietic stem cell transplantation — PROCEDURE
    Undergo transplantation
  • peripheral blood stem cell transplantation — PROCEDURE
    Undergo transplantation

Study Details

The purpose of the study is to see how well reduced intensity conditioning followed by a stem cell transplant from a donor (allogeneic) works in treating patients with severe systemic sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a healthy donor and transplanted into the patient. Stem cells can be donated by a family member or an unrelated donor who is a complete tissue type match.

Key Dates

Status verified
Oct 2012
Primary completion
Sep 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (transplant)
    Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0. Patients then undergo peripheral blood stem cell transplantation on day 0. Patients receive GVHD prophylaxis comprising tacrolimus PO twice daily on days -3 to 180 and taper and mycophenolate mofetil PO three times daily on days 0-28 and then twice daily until day 180 and taper.
  • Active Comparator: Arm II (nontransplant)
    Patients receive mycophenolate mofetil PO twice daily for 16 months, rituximab IV on days 1 and 15 and then repeated at 6 months, and cyclophosphamide IV at 28-32 day intervals or orally once daily for 16 months.

Primary Outcome Measure

Event-free survival [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

Related Studies