Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease
caused by donor stem cell transplant.
PURPOSE: This randomized clinical trial studies palifermin in preventing chronic
graft-versus-host disease in patients who have undergone donor stem cell transplant for
hematologic cancer
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Survival for more than 60 days after an allogeneic hematopoietic cell transplantation (HCT) with growth-factor mobilized blood cells - Current dose of prednisone at =< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment - Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study - Able and willing to give informed consent Exclusion Criteria: - Presence of generalized rash involving more than 50% of the body surface - Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment - Any prior local irradiation to a field that included the thymus (total body irradiation is allowed) - History of thymectomy - Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen - Use of a graft depleted of T cells - Any evidence of recurrent or persistent malignancy after HCT - Participation in another study with chronic GVHD as the primary endpoint - Any prior history of carcinoma - Any infection that is not improving during appropriate treatment - History of palifermin intolerance - A positive pregnancy test (women of child-bearing potential) - Breast feeding |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Martin, Paul | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood | RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks. | Baseline and 4 weeks after administration of palifermin | No |
| Secondary | Changes in the Number of Naive CD4 T Cells in the Blood | Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks. | Baseline and 4 weeks after administration of palifermin | No |
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