A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 74 |
Updated: | 5/16/2018 |
Start Date: | August 2016 |
End Date: | April 6, 2018 |
A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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.
of SGN-CD123A given every 3 weeks to patients.
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.
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.
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
We found this trial at
7
sites
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Harry Erba
Phone: 205-934-0314
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Amir Fathi
Phone: 617-726-5131
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Roland Walter
Phone: 206-667-1997
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Aurora, Colorado 80045
Principal Investigator: Daniel Pollyea
Phone: 720-848-2587
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Guido Marcucci
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Hawthorne, New York 10532
Principal Investigator: Karen Seiter
Phone: 914-493-8375
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Houston, Texas 77030
Principal Investigator: Farhad Ravandi-Kashani
Phone: 713-745-4367
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