Acute Myelogenous LeukemiaPhase 1NCT01902329
A Safety Study of SGN-CD33A in AML Patients
A Phase 1 study testing HMA and SGN-CD33A in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Seagen Inc. at 14 sites in United States.
Trial summary
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute Promyelocytic Leukemia
- What is being tested?
- HMA and SGN-CD33A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2013to 8 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myeloid leukemia, positive for CD33
- Eastern Cooperative Oncology Group status of 0 or 1
- Adequate baseline renal and hepatic function
- Central venous access
- Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
- Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
Who cannot join
- Inadequate lung function
- Prior allogeneic stem cell transplant, except for a specific cohort
- High-dose chemotherapy within 4 weeks of study drug
- Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic, The
Cleveland, Ohio, 44195
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246
City of Hope National Medical Center
Duarte, California, 91010-3000
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Utah
Salt Lake City, Utah, 84112
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.
Read the detailed description
This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment.
Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant.
Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.
- Being tested
- HMA, SGN-CD33A
- Keywords
- Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Immunotherapy, Drug Therapy, Acute Myelogenous Leukemia, Acute Promyelocytic Leukemia, APL
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMADrug
azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
SGN-CD33ADrug
Also called vadastuximab talirine
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD33A + HMA | Experimental | SGN-CD33A with hypomethylating agent Receives: Drug: HMA; Drug: SGN-CD33A |
| SGN-CD33A Monotherapy | Experimental | SGN-CD33A Receives: Drug: SGN-CD33A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Through 1 month following last dose
Incidence of laboratory abnormalities
Measured: Through 1 month following last dose
Secondary outcomes (6)
Blood concentrations of SGN-CD33A and metabolites
Measured: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose
Rate of complete remission
Measured: Up to 3 months
Duration of complete remission
Measured: Up to approximately 3 years
Relapse-free survival
Measured: Up to approximately 3 years
Overall survival
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion18 Mar 2016
- Study completion8 Dec 2017
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 Myelogenous 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 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
- NCT01902329
- Sponsor's protocol ID
- SGN33A-001
- Status last verified
- Jan 2018
- First submitted
- 15 Jul 2013
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein EM, Walter RB, Erba HP, Fathi AT, Advani AS, Lancet JE, Ravandi F, Kovacsovics T, DeAngelo DJ, Bixby D, Faderl S, Jillella AP, Ho PA, O'Meara MM, Zhao B, Biddle-Snead C, Stein AS. A phase 1 trial of vadastuximab talirine as monotherapy in patients with CD33-positive acute myeloid leukemia. Blood. 2018 Jan 25;131(4):387-396. doi: 10.1182/blood-2017-06-789800. Epub 2017 Dec 1.
PubMed 29196412
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01902329
- Acronym / sponsor ID
- SGN33A-001
- Keywords
- Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Immunotherapy, Drug Therapy, Acute Myelogenous Leukemia, Acute Promyelocytic Leukemia, APL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 18 Jul 2013 (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.
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.
Detailed description
This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment.
Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant.
Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGN-CD33A + HMA | Experimental | Drug: HMA, Drug: SGN-CD33ASGN-CD33A with hypomethylating agent |
| SGN-CD33A Monotherapy | Experimental | Drug: SGN-CD33ASGN-CD33A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute myeloid leukemia, positive for CD33
- Eastern Cooperative Oncology Group status of 0 or 1
- Adequate baseline renal and hepatic function
- Central venous access
- Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
Key exclusion criteria (4 listed)
- Inadequate lung function
- Prior allogeneic stem cell transplant, except for a specific cohort
- High-dose chemotherapy within 4 weeks of study drug
- Antileukemia treatment within 14 days 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 |
|---|---|---|
| HMAazacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days | Drug | SGN-CD33A + HMA |
| SGN-CD33AAlso: vadastuximab talirineGiven intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA) | Drug | SGN-CD33A + HMA, SGN-CD33A Monotherapy |
Primary outcome
Incidence of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
6 secondary outcomes
Blood concentrations of SGN-CD33A and metabolites
Time frame: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose
Rate of complete remission
Time frame: Up to 3 months
Duration of complete remission
Time frame: Up to approximately 3 years
Relapse-free survival
Time frame: Up to approximately 3 years
Overall survival
Time frame: Up to approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 29196412Stein EM, Walter RB, Erba HP, Fathi AT, Advani AS, Lancet JE, Ravandi F, Kovacsovics T, DeAngelo DJ, Bixby D, Faderl S, Jillella AP, Ho PA, O'Meara MM, Zhao B, Biddle-Snead C, Stein AS. A phase 1 trial of vadastuximab talirine as monotherapy in patients with CD33-positive acute myeloid leukemia. Blood. 2018 Jan 25;131(4):387-396. doi: 10.1182/blood-2017-06-789800. Epub 2017 Dec 1.
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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.
14 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 HMA and SGN-CD33A in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Seagen Inc. at 14 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (time frame: Through 1 month following last dose). The study lists 2 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 NCT01902329, 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 5 Jan 2018.