Trial Outcomes & Findings for Campath Maintenance in Chronic Lymphocytic Leukemia (NCT NCT00587847)

NCT ID: NCT00587847

Last Updated: 2015-10-15

Results Overview

Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Every 8 weeks
• Results posted on: 2015-10-15

Participant Flow

The study was originally designed to recruit 20 patients but only 12 subjects were accrued to the trial before it was stopped due to poor recruitment. Subjects were entered between August 2005 and July 2007. All subjects had Chronic Lymphocytic Leukemia that was previously treated with chemotherapy.

Participant milestones

Measure	Single Arm, Open Label Trial. single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Overall Study STARTED	12
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Single Arm, Open Label Trial. single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Overall Study Lack of Efficacy	5
Overall Study Adverse Event	2

Baseline Characteristics

Campath Maintenance in Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Measure	Single Arm, Open Label Trial. n=12 Participants single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
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	6 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks

Population: All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.

Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.

Outcome measures

Measure	Single Arm, Open Label Trial. n=12 Participants single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Time to Progression (Months)	10 months Interval 3.0 to 22.0

SECONDARY outcome

Timeframe: Weekly then every 2 weeks then every 3 weeks

Population: All participants who received at least one dose of alemtuzumab were analyzed for safety.

Number of participants who developed clinical or laboratory evidence of infection.

Outcome measures

Measure	Single Arm, Open Label Trial. n=12 Participants single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Rate of Infections	2 participants

Adverse Events

Single Arm, Open Label Trial.

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm, Open Label Trial. n=12 participants at risk single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
General disorders Injection Site reaction	16.7% 2/12 • Number of events 2
Infections and infestations Lung infection	8.3% 1/12 • Number of events 1
Immune system disorders Autoimmune disorder	16.7% 2/12 • Number of events 2

Additional Information

Kanti Rai, MD

North Shore-Long Island Jewish Health System

Phone: (718) 470-4050

Email: krai@nshs.edu

Results disclosure agreements

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