Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
The purposes of this trial are:
1. 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.
2. 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.
3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous
infusion followed by a subcutaneous injection.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (CR+PR) to CAMPATH-1H
Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.
Alessandra Ferrajoli, M.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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