CAM203.

Trial name or title	Subcutaneous alemtuzumab (CAMPATH®, MabCampath®) in relapsed/refractory B‐CLL
Methods	A phase II trial to evaluate the efficacy and safety of SC administered alemtuzumab in patients with previously treated B‐CLL. Randomisation Two arms: alemtuzumab (dose escalation) versus alemtuzumab (no escalation)
Participants	Inclusion criteria A diagnosis of B‐cell CLL; according to the NCI WG Criteria WHO performance status of 0, 1, or 2 Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One therapy regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months Patient requires treatment for CLL per the following criteria: Rai stage III or IV; Rai stage 0‐II with at least one of the following ‐ evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia; Massive or progressive splenomegaly; Progressive lymphocytosis with an increase of greater than 50% over a 2‐month period or an anticipated doubling time of less than 6 months; Lymphocyte count > 100 x 109/L; B‐symptoms More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy Exclusion criteria Previously treated with alemtuzumab Previous bone marrow transplant
Interventions	Alemtuzumab (dose escalation) The dose is escalated as tolerated using 3mg,10mg, and 30mg, administered SC (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks. Alemtuzumab (no escalation) All patients will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week for up to 18 weeks.
Outcomes	Primary outcome Best disease response to alemtuzumab treatment administered SC for up to 18 weeks in patients with (B‐cell CLL) [Time Frame: 44 weeks with additional observation period thereafter] Secondary outcome PFS Duration of response OS MRD Safety
Starting date	May 18, 2006
Contact information	Genzyme
Notes	Sponsor: Genzyme Estimated enrolment: 85 Estimated primary completion date: July 2011 (Final data collection date for primary outcome measure) Study status according to ClinicalTrials.gov: This study is ongoing, but not recruiting participants.