Campath Maintenance in Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00587847|
Recruitment Status : Terminated (Insufficient recruitment.)
First Posted : January 8, 2008
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Campath||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Campath maintenance treatment
Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Other Name: Alemtuzumab
- Time to Progression (Months) [ Time Frame: Every 8 weeks ]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.
- Rate of Infections [ Time Frame: Weekly then every 2 weeks then every 3 weeks ]Number of participants who developed clinical or laboratory evidence of infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587847
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Kanti R. Rai, MD||Long Island Jewish Medical Center|