Acute Myeloid LeukemiaPhase 1NCT02848248
A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
A Phase 1 study testing SGN-CD123A in people with Acute Myeloid Leukemia, run by Seagen Inc. at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- SGN-CD123A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2016to 6 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Hospital / University of Colorado
Aurora, Colorado, 80045-0510
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
City of Hope National Medical Center
Duarte, California, 91010-3000
Hudson Valley Hematology and Oncology Associates/New York Medical College
Hawthorne, New York, 10532-2168
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: 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.
Read the detailed description
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:
- Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
- 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
- Acute Myeloid Leukemia
- Being tested
- SGN-CD123A
- Keywords
- Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD123 Antigen, Drug Therapy, AML, Leukemia, Myeloid, Acute
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-CD123ADrug
Intravenous infusion in 3-week cycles
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD123A | Experimental | SGN-CD123A every 3 weeks Receives: Drug: SGN-CD123A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, seriousness, and relatedness of adverse events
Measured: Through 1 month following last dose, or end-of-treatment visit whichever is later
Type, incidence, and severity of laboratory abnormalities
Measured: Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of dose-limiting toxicity
Measured: First cycle of treatment, 3 weeks
Secondary outcomes (6)
Blood concentrations of SGN-CD123A, total antibodies, and metabolites
Measured: Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose, or end-of-treatment visit whichever is later
Rate of remission
Measured: Through 1 month following last dose, or end-of-treatment visit whichever is later
Duration of complete remission
Measured: Up to approximately 1 year
Leukemia-free survival
Measured: Up to approximately 1 year
Overall survival
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phoenix Ho, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848248
- Sponsor's protocol ID
- SGN123-001
- Status last verified
- May 2018
- First submitted
- 25 Jul 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Li F, Sutherland MK, Yu C, Walter RB, Westendorf L, Valliere-Douglass J, Pan L, Cronkite A, Sussman D, Klussman K, Ulrich M, Anderson ME, Stone IJ, Zeng W, Jonas M, Lewis TS, Goswami M, Wang SA, Senter PD, Law CL, Feldman EJ, Benjamin DR. Characterization of SGN-CD123A, A Potent CD123-Directed Antibody-Drug Conjugate for Acute Myeloid Leukemia. Mol Cancer Ther. 2018 Feb;17(2):554-564. doi: 10.1158/1535-7163.MCT-17-0742. Epub 2017 Nov 15.
PubMed 29142066
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT02848248
- Acronym / sponsor ID
- SGN123-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD123 Antigen, Drug Therapy, AML, Leukemia, Myeloid, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-CD123A | Experimental | Drug: SGN-CD123ASGN-CD123A every 3 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-CD123AIntravenous infusion in 3-week cycles | Drug | SGN-CD123A |
Primary outcome
Type, incidence, severity, seriousness, and relatedness of adverse events
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Type, incidence, and severity of laboratory abnormalities
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of dose-limiting toxicity
Time frame: First cycle of treatment, 3 weeks
6 secondary outcomes
Blood concentrations of SGN-CD123A, total antibodies, and metabolites
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Rate of remission
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Duration of complete remission
Time frame: Up to approximately 1 year
Leukemia-free survival
Time frame: Up to approximately 1 year
Overall survival
Time frame: Up to approximately 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 29142066Li F, Sutherland MK, Yu C, Walter RB, Westendorf L, Valliere-Douglass J, Pan L, Cronkite A, Sussman D, Klussman K, Ulrich M, Anderson ME, Stone IJ, Zeng W, Jonas M, Lewis TS, Goswami M, Wang SA, Senter PD, Law CL, Feldman EJ, Benjamin DR. Characterization of SGN-CD123A, A Potent CD123-Directed Antibody-Drug Conjugate for Acute Myeloid Leukemia. Mol Cancer Ther. 2018 Feb;17(2):554-564. doi: 10.1158/1535-7163.MCT-17-0742. Epub 2017 Nov 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phoenix Ho, MD study director
Seagen Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-CD123A in people with Acute Myeloid Leukemia, run by Seagen Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence, severity, seriousness, and relatedness of adverse events (time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.