A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This clinical trial will be a multicenter phase II fixed-dose trial in which a minimum of 10
patients with immunophenotypically confirmed ATL with at least 50% of the blasts expressing
CD25 as measured by flow cytometry at relapse, will receive Imtox-25. Patients are eligible
for repeat courses of treatment every two weeks if they do not experience a dose limiting
toxicity (DLT) as defined in Section 5.2 and do not have a HAMA/HARA level > 1 μg/ml. The
treatment will be administered in the in-patient setting. If no response is observed among
the initial 9 patients, the study would be terminated early and declared negative; if at
least one response is observed, accrual would continue to a total of 17 evaluable patients
(total study size=19 to account for 10% of the patients being unevaluable for any reason).
Phase:
Phase 2
Details
Lead Sponsor:
Albert Einstein College of Medicine of Yeshiva University Amit Verma