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Mechanistic Study: Molecular Analysis of T Cell Immune Recovery for the SCOT Trial

Phase 2/Phase 3
18 Years
69 Years
Not Enrolling
Scleroderma, Systemic, Sclerosis

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Trial Information

Mechanistic Study: Molecular Analysis of T Cell Immune Recovery for the SCOT Trial

The purpose of this mechanistic study is [1] to describe the condition of peripheral T cell
reactivity and repertoire diversity in SSc patients and evaluate evidence for potential
defects prior to randomization, [2] to gain a better understanding of the impact of
cyclophosphamide (CY) and high-dose immunosuppressive therapy with autologous peripheral
blood stem cell transplantation (HDIT-transplantation) on thymopoiesis, and [3] to describe
the kinetics and breadth of T cell immune recovery in SSc patients treated with

Recruitment for this study will be limited to participants who have elected to participate
in the SCOT study and have been randomized to one of the SCOT treatment arms. Participants
will be recruited after randomization to ensure balance on the two arms for this mechanistic
study and must agree to participate and sign an informed consent for this mechanistic study
prior to initiation of treatment on either arm. Sixty participants, 30 from each arm, will
be recruited for this sub-study. It will be conducted at the participating SCOT transplant

Peripheral blood samples will be collected (20 mL) pre-treatment (prior to first infusion
for cyclophosphamide arm or mobilization for transplant arm) and approximately 6, 12, 24,
36, and 48 months post completion of treatment to be aligned with the regularly scheduled
SCOT protocol visits. Specific measures will be the level of peripheral blood T Cell
Receptor Excision Circles (sjTREC) and peripheral blood T cell receptor Vbeta repertoire
diversity before and after completion of randomized therapy.

Inclusion Criteria:

- Participation in DAIT SCSSc-01 (SCOT Trial)

Exclusion Criteria:

- No additional exclusion criteria

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Condition of periphertal T-cell reactivity and repertoire diversity and potential defects

Outcome Time Frame:

At study entry

Safety Issue:


Principal Investigator

Gregory D. Sempowski, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University Human Vaccine Institute


United States: Food and Drug Administration

Study ID:

DAIT SCSSc-01-03



Start Date:

March 2009

Completion Date:

March 2016

Related Keywords:

  • Scleroderma, Systemic
  • Sclerosis
  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Scleroderma, Localized
  • Sclerosis



University of Michigan Ann Arbor, Michigan  48109-0624
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Boston University School of Medicine Boston, Massachusetts  02118
City of Hope National Medical Center Los Angeles, California  91010
Duke University Durham, North Carolina  27710
UCLA Medical School Los Angeles, California  90095-1670
Fred Hutchinson Cancer Research Center (FHCRC) Seattle, Washington  98109
University of Texas - Houston Medical School Houston, Texas