A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure
I. Determine the response rate to alemtuzumab alone and in combination with methotrexate
and mercaptopurine in children with acute lymphoblastic leukemia in second or greater
relapse or twice induction failure.
II. Determine the toxicity of these regimens in these patients.
I. Determine the pharmacokinetics of alemtuzumab in these patients. II. Determine the immune
response in patients treated with alemtuzumab. III. Determine changes in the number of
CD52-positive cells in the blood and marrow of patients treated with alemtuzumab.
IV. Determine the rate and timing of clearance of peripheral circulating lymphoblasts in
patients treated with these regimens.
OUTLINE: This is a multicenter study.
Course 1: Patients receive alemtuzumab IV over 2 hours on days 1-5, 8, 10, 12, 15, 17, 19,
22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Patients
achieving complete remission (CR), partial remission (PR), or cytolytic PR at day 29, or
patients with CNS disease that achieve a CNS 1 or CNS 2 status, proceed to course 2.
Courses 2 and 3: Patients receive alemtuzumab IV over 2 hours on days 1, 8, 15, and 22;
methotrexate IV continuously over 24 hours on day 1 and then orally once daily on days 8,
15, and 22; and oral mercaptopurine once daily on days 1-28. Patients with a CR or PR at
day 29 proceed to course 3. In course 3, patients receive alemtuzumab, methotrexate, and
mercaptopurine as in course 2.
CNS prophylaxis*: Patients receive methotrexate intrathecally on day 1 of courses 2 and 3
on day 1 of courses 2 and 3.
NOTE: * CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and
day 1 of courses 2 and 3.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate to Campath-1H alone
Day 29, course 1
COG Phase I Consortium
United States: Food and Drug Administration
|COG Phase I Consortium||Arcadia, California 91006-3776|