Small Lymphocytic Leukemia Clinical Trial
Official title:
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This Phase I, multiple ascending dose study will seek to enroll subjects with relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with confirmed and measurable disease who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that resulted in initial response, followed by relapse/recurrence and who are not eligible for any further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from any therapy of higher priority by Investigator assessment.
This study is intended to provide investigators and sponsor with the following information
regarding the investigational new drug MT-3724 in patients with relapsed/refractory Chronic
B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma:
The maximum dose of a single course of MT-3724 given as intravenous (IV) infusions on Days
1, 3, 5, 8, 10 and 12 at which there are negligible side effects and/or at which maximum
serum levels and/or at which maximum effect on blood lymphocytes are observed. Four dose
levels will be investigated.
The changes in MT-3724 serum levels and blood lymphocytes over time following IV doses at
different points in the study.
The changes and kinds of clinical and laboratory effects and side effects that may occur
over repeated courses of MT-3724 The changes in each subject's immune status and their CLL
or SLL following one or more cycles of 6 infusions.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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