N/A
N=6
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
Accelerated Phase Chronic Myelogenous Leukemia · Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Myeloid Leukemia in Remission · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q)
Bottom Line
View on ClinicalTrials.gov: NCT01233921 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood — -2; -22 cells per microliter of blood
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- palifermin (Biological); flow cytometry (Other); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Martin, Paul
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood |
-2; -22 | — |
| SECONDARY Changes in the Number of Naive CD4 T Cells in the Blood |
-3; -25 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01233921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.