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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00622895 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of abnormal cells. It also may stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation followed by a donor peripheral stem cell transplant works in treating patients with severe systemic sclerosis.
Condition | Intervention | Phase |
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Precancerous/Nonmalignant Condition |
Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis |
Estimated Enrollment: | 20 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed periodically after transplantation.
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At high-risk for a fatal outcome based on the following prognostic factors from any of the following groups as defined below:
Group 1: Patients must meet both of the first two criteria AND ≥ 1 of the last three criteria, including the following:
Left heart failure with LVEF < 50%, pericardial effusion (mild-moderate), or second- or third-degree atrioventricular block
Group 2: Patients must have progressive pulmonary disease as the primary indication for transplant, as defined by a decrease in the FVC or DLCO by ≥ 15% within the past 12 months AND evidence of alveolitis (abnormal chest CT scan or BAL)
Group 3: Patients must have progressive active SSc after prior autologous stem cell transplant (SCT) based on the presence of progressive pulmonary disease
Failed one of the following oral or IV cyclophosphamide regimens (unless corrected DLCO < 45% of predicted):
Ineligible for FHCRC-1948 (SCOT clinical trial)
HLA genotypically identical sibling or unrelated donor available
PATIENT CHARACTERISTICS:
No organ dysfunction as defined by any of the following criteria:
Significant uncontrolled pulmonary hypertension, defined by any of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: V. K. Gadi, MD, PhD 206-667-1256 |
Principal Investigator: | V. K. Gadi, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( V. K. Gadi ) |
Study ID Numbers: | CDR0000583091, FHCRC-2067.00 |
Study First Received: | February 22, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00622895 |
Health Authority: | Unspecified |
systemic scleroderma |
Skin Diseases Precancerous Conditions Mycophenolate mofetil Connective Tissue Diseases Sclerosis |
Scleroderma, Systemic Tacrolimus Fludarabine Fludarabine monophosphate |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |