Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure
This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
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