Trial Outcomes & Findings for A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF (NCT NCT00208949)

NCT ID: NCT00208949

Last Updated: 2012-09-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: at transplant (1 day)
• Results posted on: 2012-09-14

Participant Flow

Participant milestones

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) Single use of G-CSF	G-CSF and GM-CSF (Granulocyte Macrophage) Combined use of G-CSF and GM-CSF
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

Baseline characteristics by cohort

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) n=25 Participants Single use of G-CSF	G-CSF and GM-CSF (Granulocyte Macrophage) n=25 Participants Combined use of G-CSF and GM-CSF	Total n=50 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	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized	43 years n=5 Participants	53 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: at transplant (1 day)

Population: Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).

Outcome measures

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) n=25 Participants Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day	G-CSF and GM-CSF (Granulocyte Macrophage) n=25 Participants Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft	4 x10 ^ 6 cells/kg Standard Error 1	2.5 x10 ^ 6 cells/kg Standard Error 1

SECONDARY outcome

Timeframe: 5 years

Median overall survival

Outcome measures

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) n=25 Participants Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day	G-CSF and GM-CSF (Granulocyte Macrophage) n=25 Participants Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.	38.3 months Interval 0.0 to 60.0	7.3 months Interval 0.0 to 60.0

Adverse Events

G-CSF (Granulocyte Colony- Stimulating Factor)

Serious events: 7 serious events

Other events: 17 other events

Deaths: 0 deaths

G-CSF and GM-CSF (Granulocyte Macrophage)

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) n=25 participants at risk Single use of G-CSF	G-CSF and GM-CSF (Granulocyte Macrophage) n=25 participants at risk Combined use of G-CSF and GM-CSF
Blood and lymphatic system disorders Death	28.0% 7/25	28.0% 7/25

Other adverse events

Measure	G-CSF (Granulocyte Colony- Stimulating Factor) n=25 participants at risk Single use of G-CSF	G-CSF and GM-CSF (Granulocyte Macrophage) n=25 participants at risk Combined use of G-CSF and GM-CSF
General disorders Fever	8.0% 2/25	36.0% 9/25
Musculoskeletal and connective tissue disorders Bone Pain	48.0% 12/25	76.0% 19/25
Skin and subcutaneous tissue disorders Injection site redness	4.0% 1/25	12.0% 3/25
Musculoskeletal and connective tissue disorders Injected site pain	8.0% 2/25	20.0% 5/25

Additional Information

Dr. Sagar Lonial

Emory University

Phone: 404-778-1900

Email: SLONI01@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place