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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES: 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 2. SECONDARY OBJECTIVES: 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 interval. EXPLORATORY OBJECTIVES: 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03698552
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Nitin Jain
Phone 713-745-6080
Email njain@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date August 24, 2018
Completion date December 31, 2025

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