ADCT-602 in Treating Patients with Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT03698552
Trial Phases:	Phase I Phase II	Protocol IDs:	2017-0938 (primary) NCI-2018-02016
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	M D Anderson Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03698552

Summary

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
I. Evaluate the safety and determine the maximum tolerated dose (MTD) of epratuzumab-cys-tesirine (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 epratuzumab-cys-tesirine intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive epratuzumab-cys-tesirine every 28 days.

Patients may undergo bone marrow aspirate and biopsy at screening, end of cycle 1, after cycles 2 and 3, and end of treatment.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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