Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of
age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of
B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have
been used to treat patients with leukemia in other research studies like this one. Both drugs
have individually been administered to adult patients with ALL with acceptable toxicity
profiles. This study will evaluate the combination of clofarabine and alemtuzumab when
administered to adult patients with relapsed or refractory ALL. Primary objectives of the
study is to determine the maximum tolerated dose of clofarabine when administered with
alemtuzumab, evaluate the safety of the combination, and assess for activity of the
combination by evaluating response rate, effect on ALL progenitor cell population, and
patients who are able to bridge to transplant.