An interventional study of palifermin and flow cytometry in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by Martin, Paul. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-02.
Sponsored by Martin, Paul · Not applicable, Interventional, and Supportive care
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
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 6 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Martin, Paul is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Biological: palifermin · Other: flow cytometry · Other: laboratory biomarker analysis · Other: pharmacological study
Patients do not receive palifermin.
Other: flow cytometry · Other: laboratory biomarker analysis · Other: pharmacological study
Given IV
Also known as: growth factor, recombinant human keratinocyte, Kepivance, keratinocyte growth factor, recombinant human, recombinant human keratinocyte growth factor, rhKGF
Correlative studies
Correlative studies
Correlative studies
Also known as: pharmacological studies
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.
Time frame: Baseline and 4 weeks after administration of palifermin
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.
Time frame: Baseline and 4 weeks after administration of palifermin
Subjects were enrolled between Nov 2010 and June 2012 during outpatient follow-up after allogeneic hematopoietic cell tranpslantation.
| Milestone | Arm I (Palifermin) | Arm II (no Palifermin) |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
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.
| cells per microliter of blood | Arm I (Palifermin) | Arm II (no Palifermin) |
|---|---|---|
| Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood | -2 ± 3 | -22 ± 51 |
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.
| cells per microliter of blood | Arm I (Palifermin) | Arm II (no Palifermin) |
|---|---|---|
| Changes in the Number of Naive CD4 T Cells in the Blood | -3 ± 4 | -25 ± 58 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Palifermin) | — | 0/3 (0%) | 3/3 (100%) |
| Arm II (no Palifermin) | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | Arm I (Palifermin) | Arm II (no Palifermin) |
|---|---|---|
| oral mucosal changeGastrointestinal disorders | 3/3 | 0/3 |
| diarrheaGastrointestinal disorders | 3/3 | 1/3 |
| rashSkin and subcutaneous tissue disorders | 2/3 | 1/3 |
| painMusculoskeletal and connective tissue disorders | 2/3 | 1/3 |
| arthralgiaMusculoskeletal and connective tissue disorders | 2/3 | 0/3 |
| anorexiaGastrointestinal disorders | 2/3 | 0/3 |
| nauseaGastrointestinal disorders | 2/3 | 0/3 |
| pruritisSkin and subcutaneous tissue disorders | 0/3 | 1/3 |
| edemaGeneral disorders | 1/3 | 0/3 |
| vomitingGastrointestinal disorders | 1/3 | 0/3 |
| Age, Categorical(Participants) | Arm I (Palifermin) | Arm II (no Palifermin) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm I (Palifermin) | Arm II (no Palifermin) | Total |
|---|---|---|---|
| Mean | 44 ± 13 | 41 ± 11 | 43 ± 11 |
| Sex: Female, Male(Participants) | Arm I (Palifermin) | Arm II (no Palifermin) | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 2 | 3 | 5 |
| Region of Enrollment(participants) | Arm I (Palifermin) | Arm II (no Palifermin) | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Martin, Paul