A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-04-06

Brief Summary

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The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

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Detailed Description

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This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts:

1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels

Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles.

After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A.

For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SGN-CD123A

SGN-CD123A every 3 weeks

Group Type EXPERIMENTAL

SGN-CD123A

Intervention Type DRUG

Intravenous infusion in 3-week cycles

Interventions

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SGN-CD123A

Intravenous infusion in 3-week cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
* Patients may be eligible after only 1 previous regimen if in a high risk category
* Adequate baseline renal and hepatic function
* Eastern Cooperative Oncology Group Status of 0 or 1
* CD123-detectable leukemia

Exclusion Criteria

* Cerebral/meningeal disease related to underlying malignancy
* Promyelocytic leukemia
* History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide \<50% predicted
* Prior hematopoietic stem cell transplant
* Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)
* Cardio or cerebral vascular event within 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No