Myelodysplastic SyndromePhase 1/2NCT02706899
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
A Phase 1/2 study testing vadastuximab talirine and Azacitidine in people with Myelodysplastic Syndrome, run by Seagen Inc. at 34 sites in United States.
Trial summary
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- vadastuximab talirine and Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 34 sitesUnited States
- Study dates
- Feb 2016to 6 Nov 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
- Previously untreated for Myelodysplastic Syndrome (MDS)
- Age ≥18 years of age.
- Eligible for therapy with azacitidine.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate baseline laboratory parameters.
Who cannot join
- Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
- History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
- Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
- Candidates for allogeneic stem cell transplant at the time of screening.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
The University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan
Georgia Regents University Hospital
Augusta, Georgia
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado
Texas Oncology - Austin Midtown
Austin, Texas
Center for Cancer and Blood Disorders
Bethesda, Maryland
Bozeman Deaconess Health Group
Bozeman, Montana
Weill Cornell
Brooklyn, New York
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina
Rush University Medical Center
Chicago, Illinois
Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
Cleveland, Ohio
Ohio State University
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas
Colorado Blood Cancer Institute
Denver, Colorado
University of Colorado Hospital
Denver, Colorado
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan
Cancer Specialisits of North Florida
Fleming Island, Florida
Banner MD Anderson Cancer Center
Gilbert, Arizona
Hackensack University Medical Center
Hackensack, New Jersey
Westchester Medical Center
Hawthorne, New York, 10532
MD Anderson Cancer Center
Houston, Texas
Mayo Clinic
Jacksonville, Florida, 32224
University of Southern California
Los Angeles, California, 90033
Froedtert & Medical College of Wisconson Clinical Cancer Center
Milwaukee, Wisconsin
University of Minnesota Medical Center (UMMC)
Minneapolis, Minnesota
Tennessee Oncology, PLLC
Nashville, Tennessee
Columbia University Medical Center
New York, New York
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania
Providence Portland Research Center
Portland, Oregon, 97213
Oregon Health & Science
Portland, Oregon, 97239
Cancer Care Centers of South Texas
San Antonio, Texas
Swedish Medical Center
Seattle, Washington
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).
Read the detailed description
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- vadastuximab talirine, Azacitidine, Placebo (for 33A)
- Keywords
- Antibody-Drug Conjugate CD33 Antigen
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vadastuximab talirineDrug
Also called 33A, SGN-CD33A
Intravenous (IV) push every 4 weeks
AzacitidineDrug
75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks
Placebo (for 33A)Drug
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 33A + azacitidine | Experimental | Vadastuximab talirine plus azacitidine Receives: Drug: vadastuximab talirine; Drug: Azacitidine |
| Placebo + azacitidine | Active comparator | placebo plus azacitidine Receives: Drug: Azacitidine; Drug: Placebo (for 33A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Measured: Up to 1 year
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
Measured: N/A - End point not assessed
Secondary outcomes (7)
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.
Measured: Up to 1 year
Complete Response Rate (CR)
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.
Measured: N/A - End point not assessed
Hematologic Improvement (HI) Rate
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.
Measured: N/A - End point not assessed
Duration of Response (DOR) Rate
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.
Measured: N/A - End point not assessed
Progression Free Survival (PFS)
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Measured: N/A - End point not assessed
Rate of Transformation to Acute Myeloid Leukemia (AML)
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.
Measured: N/A - End point not assessed
Overall Survival (OS)
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.
Measured: N/A - End point not assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Garfin, Study chair, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706899
- Sponsor's protocol ID
- SGN33A-004
- Status last verified
- Jan 2019
- First submitted
- 19 Feb 2016
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT02706899
- Acronym / sponsor ID
- SGN33A-004
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Antibody-Drug Conjugate CD33 Antigen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Posted 21 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).
Detailed description
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 33A + azacitidine | Experimental | Drug: vadastuximab talirine, Drug: AzacitidineVadastuximab talirine plus azacitidine |
| Placebo + azacitidine | Active comparator | Drug: Azacitidine, Drug: Placebo (for 33A)placebo plus azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
- Previously untreated for Myelodysplastic Syndrome (MDS)
- Age ≥18 years of age.
- Eligible for therapy with azacitidine.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (4 listed)
- Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
- History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
- Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
- Candidates for allogeneic stem cell transplant at the time of screening.
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 |
|---|---|---|
| vadastuximab talirineAlso: 33A, SGN-CD33AIntravenous (IV) push every 4 weeks | Drug | 33A + azacitidine |
| Azacitidine75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks | Drug | 33A + azacitidine, Placebo + azacitidine |
| Placebo (for 33A)Placebo supplied in single-use vials matching 33A, IV push every 4 weeks | Drug | Placebo + azacitidine |
Primary outcome
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Time frame: Up to 1 year
A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
Time frame: N/A - End point not assessed
7 secondary outcomes
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Time frame: Up to 1 year
Complete Response Rate (CR)
Time frame: N/A - End point not assessed
Hematologic Improvement (HI) Rate
Time frame: N/A - End point not assessed
Duration of Response (DOR) Rate
Time frame: N/A - End point not assessed
Progression Free Survival (PFS)
Time frame: N/A - End point not assessed
Rate of Transformation to Acute Myeloid Leukemia (AML)
Time frame: N/A - End point not assessed
Overall Survival (OS)
Time frame: N/A - End point not assessed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Phillip Garfin study chair
Seagen Inc.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing vadastuximab talirine and Azacitidine in people with Myelodysplastic Syndrome, run by Seagen Inc. at 34 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 7 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: stopped early, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study (time frame: Up to 1 year). 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?
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 12 Feb 2019.