Acute Myeloid Leukemia Clinical Trial
Official title:
A PHASE IIA, MULTICENTER, OPEN-LABEL STUDY DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF ESCALATING DOSES OF BL-8040 IN ADULT SUBJECTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA
The goal of this clinical research study is to learn if BL-8040 in combination with cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia (AML) that has relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
Open-label, multicenter, phase IIa, dose escalating study in subjects with
relapsed/refractory AML, defined according to WHO criteria (1), including subjects who failed
chemotherapy only and those who failed previous Autologous Stem Cell Transplantation (ASCT) /
Allogeneic Stem Cell Transplantation (AlloSCT), provided at least 6 months have passed from
transplant.
Eligible subjects will receive subcutaneous (SC) injections of BL-8040 ("monotherapy period")
over two days (one injection per day) followed by concurrent administration of BL-8040 with
standard salvage chemotherapy ("combined period") over 5 days. During the "combined period,"
BL-8040 will be administered 4 hours prior to chemotherapy. The chemotherapy will consist of
cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV)
over 3 hours, for 5 days and will not be escalated.
The first part of the study (Part 1) will include escalating dose groups and be considered
the 'escalation phase'. Six potential dose levels (see Table 1) will be investigated starting
at dose level 1. Patients will be accrued in a conventional 3+3 design. Applying this study
design, the first cohort of 3 patients will be treated at dose level 1 and evaluated for dose
escalation.
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