Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

Not Applicable

Completed

Conditions: 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)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative

Interventions: Biological: palifermin
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study

Brief 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

Detailed Description: OBJECTIVES:

I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD).

II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.

OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not.

GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity.

GROUP 2: Patients do not receive palifermin.

After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Arm I (palifermin)	flow cytometry	Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Arm I (palifermin)	laboratory biomarker analysis	Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Arm I (palifermin)	pharmacological study	Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Arm I (palifermin)	palifermin	Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Arm II (no palifermin)	flow cytometry	Patients do not receive palifermin.
Arm II (no palifermin)	laboratory biomarker analysis	Patients do not receive palifermin.
Arm II (no palifermin)	pharmacological study	Patients do not receive palifermin.

Primary Outcome Measures

Name	Time	Method
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood	Baseline and 4 weeks after administration of palifermin	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the Number of Naive CD4 T Cells in the Blood	Baseline and 4 weeks after administration of palifermin	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.