Trial Outcomes & Findings for Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease (NCT NCT01226420)

Results Overview

Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2013-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Alefacept Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alefacept n=6 Participants Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All enrolled subjects

Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.

Outcome measures

Outcome measures
Measure	Alefacept n=6 Participants Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
Efficacy	4 participants

SECONDARY outcome

Timeframe: 2 years

Population: All enrolled subjects were included in the Analysis of Safety Events

Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.

Outcome measures

Outcome measures
Measure	Alefacept n=6 Participants Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
Safety of Alefacept Infusions in Patients With Chronic GVHD.	2 Total adverse events

Adverse Events

Alefacept

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alefacept n=6 participants at risk Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
Infections and infestations Infection (otitis externa)	16.7% 1/6 • Number of events 1
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Number of events 1
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Corey S. Cutler, MD, MPH, FRCP(C)

Dana-Farber Cancer Institute

Phone: 617-632-5946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place