Clinical trial · Interventional
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
NCT01233921CI-TRIAL-00014164completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (89)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| palifermin | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (palifermin)
- description
- Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
- interventionNames
- Biological: palifermin
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: pharmacological study
- type
- ACTIVE_COMPARATOR
- label
- Arm II (no palifermin)
- description
- Patients do not receive palifermin.
- interventionNames
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.