Trial Outcomes & Findings for Campath in Chronic GVHD (NCT NCT00495755)

NCT ID: NCT00495755

Last Updated: 2013-08-09

Results Overview

MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2013-08-09

Participant Flow

Participant milestones

Measure	Campath (Alemtuzumab) 3 dose cohorts entered
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Campath (Alemtuzumab) 3 dose cohorts entered
Overall Study Adverse Event	3

Baseline Characteristics

Campath in Chronic GVHD

Baseline characteristics by cohort

Measure	Campath (Alemtuzumab) n=13 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity

Outcome measures

Measure	Maximum Tolerated Dose (MTD) n=13 Participants
The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids	53 mg

SECONDARY outcome

Timeframe: 12 weeks

Efficacy measured as complete response (CR), partial response (PR), stable disease (SD) and cGVHD progression (PD). CR is defined as absence of all measurable or symptomatic cGVHD, PR is defined as a remission in some but not all involved organs. SD is defined as no measurable change in GVHD and PD is defined as progression in at least one involved organ.

Outcome measures

Measure	Maximum Tolerated Dose (MTD) n=10 Participants
The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD). Complete Response	3 participants
The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD). Partial Response	4 participants
The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD). Stable Disease	2 participants
The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD). cGVHD progression	1 participants

SECONDARY outcome

Timeframe: 12

Outcome measures

Outcome data not reported

Adverse Events

Campath (Alemtuzumab)

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Campath (Alemtuzumab) n=13 participants at risk
Respiratory, thoracic and mediastinal disorders Parainfluenza	15.4% 2/13 • Number of events 2
Respiratory, thoracic and mediastinal disorders Influenza A infection	7.7% 1/13 • Number of events 1
Renal and urinary disorders BK virus infection	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Adenovirus infection	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pseudomonas infection	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders E.Coli bacteremia	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Perirectal abscess	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Corynebacterium infection	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders Neutropenia	23.1% 3/13 • Number of events 3
Blood and lymphatic system disorders Thrombocytopenia	15.4% 2/13 • Number of events 2

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: cscutler@partners.org

Results disclosure agreements

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