This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients
with B-cell lymphoblastic leukemia that has come back or does not respond to treatment.
Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to
grow and spread.
I. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients
with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1.
II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy
(complete response [CR] with incomplete marrow recovery [CR/CRi] rate) of ADCT-602 in Phase
I. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall
survival (OS), and progression-free survival (PFS).
II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the
immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT
I. Obtain preliminary data on the correlation between the clinical activity and PK profile of
ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD)
markers in peripheral blood.
II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK.
OUTLINE: This is a dose escalation study followed by a phase II study.
Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every
21 in the absence of disease progression or unacceptable toxicity. Patients who achieve
CR/CRi receive ADCT-602 every 28 days.
After completion of study treatment, patients are followed up at 30 days and then every 12
weeks for up to 1 year.
Blasts 5 Percent or More of Bone Marrow Nucleated Cells, CD22 Positive, Philadelphia Chromosome Positive, Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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