Finding studies
Finding studies
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Lead
Northwestern University
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib in patients with relapsed/refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). SECONDARY OBJECTIVES: I. To evaluate the toxicities and safety profile of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL. II. To determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib. III. To determine the rate of molecular remission after three cycles of nivolumab and dasatinib. IV. To study the pharmacokinetics of nivolumab and dasatinib. V. To evaluate programmed cell death 1 (PD1) expression levels and saturation in the peripheral blood and bone marrow. VI. To measure peripheral T-cell levels and activation in response to treatment. TERTIARY OBJECTIVES: I. To evaluate the 30 day mortality rate, overall survival (OS), progression free survival (PFS), and duration of remission (DOR) one year after treatment with nivolumab when given in combination with dasatinib in patients with relapsed/refractory Ph+ ALL. II. To compare the OS between patients who receive a hematopoietic stem cell transplant and those who receive no further therapy following remission. III. To evaluate for resistance mutations at the time of disease progression. OUTLINE: Patients receive dasatinib orally (PO) once daily (QD ) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or withdrawal from the study for other reasons. After completion of study treatment, patients are followed up at 30 days and then monthly for up to 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
