Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia|
- Response Rate (CR+PR) to CAMPATH-1H [ Time Frame: 3 months ] [ Designated as safety issue: No ]Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.
|Study Start Date:||October 2002|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
15 mg infused daily for continuous infusion x 7 days; starting day 10, CAMPATH-1H 30 mg subcutaneously three times weekly for 11 additional weeks.
15 mg daily infused over 24 hours, continuous infusion x 7 days (Days 1 through 7). Each 15 mg dose prepared daily, immediately prior to starting the infusion. Starting day 10, CAMPATH-1H administered at dose of 30 mg subcutaneously three times weekly for 11 additional weeks.
The purposes of this trial are:
- To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have failed fludarabine therapy.
- To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous injections to patients with previously treated CLL will improve tolerability of the agent and permit higher doses to be delivered through that route.
- To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102661
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, M.D.||M.D. Anderson Cancer Center|