Trial Outcomes & Findings for Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer (NCT NCT01233921)

Last Updated: 2014-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline and 4 weeks after administration of palifermin

Results posted on

2014-04-02

Participant Flow

Subjects were enrolled between Nov 2010 and June 2012 during outpatient follow-up after allogeneic hematopoietic cell tranpslantation.

Participant milestones

Participant milestones
Measure	Arm I (Palifermin) Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	Arm II (no Palifermin) Patients do not receive palifermin.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Palifermin) n=3 Participants Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	Arm II (no Palifermin) n=3 Participants Patients do not receive palifermin.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 13 • n=5 Participants	41 years STANDARD_DEVIATION 11 • n=7 Participants	43 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks after administration of palifermin

Outcome measures

Outcome measures
Measure	Arm I (Palifermin) n=3 Participants Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	Arm II (no Palifermin) n=3 Participants Patients do not receive palifermin.
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood	-2 cells per microliter of blood Standard Deviation 3	-22 cells per microliter of blood Standard Deviation 51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Palifermin) n=3 Participants Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	Arm II (no Palifermin) n=3 Participants Patients do not receive palifermin.
Changes in the Number of Naive CD4 T Cells in the Blood	-3 cells per microliter of blood Standard Deviation 4	-25 cells per microliter of blood Standard Deviation 58

Adverse Events

Arm I (Palifermin)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm II (no Palifermin)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (Palifermin) n=3 participants at risk Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	Arm II (no Palifermin) n=3 participants at risk Patients do not receive palifermin.
Skin and subcutaneous tissue disorders rash	66.7% 2/3	33.3% 1/3
Skin and subcutaneous tissue disorders pruritis	0.00% 0/3	33.3% 1/3
Gastrointestinal disorders oral mucosal change	100.0% 3/3	0.00% 0/3
Musculoskeletal and connective tissue disorders pain	66.7% 2/3	33.3% 1/3
Musculoskeletal and connective tissue disorders arthralgia	66.7% 2/3	0.00% 0/3
General disorders edema	33.3% 1/3	0.00% 0/3
Gastrointestinal disorders anorexia	66.7% 2/3	0.00% 0/3
Gastrointestinal disorders nausea	66.7% 2/3	0.00% 0/3
Gastrointestinal disorders vomiting	33.3% 1/3	0.00% 0/3
Gastrointestinal disorders diarrhea	100.0% 3/3	33.3% 1/3

Additional Information

Dr. Paul J. Martin

Fred Hutchinson Cancer Research Cetner

Phone: 206-667-4798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place