Acute Myeloid LeukemiaPhase 2NCT00528333
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
A Phase 2 study testing Lintuzumab (SGN-33) and Low dose cytarabine in people with Acute Myeloid Leukemia, run by Seagen Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Lintuzumab (SGN-33) and Low dose cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 2007to Aug 2010
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
- After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
- At least 20% blasts in blood or marrow.
- Must have a minimum of 50% leukemic blasts that express CD33.
- ECOG performance status score of 0 to 2.
- WBC less than 30,000/µL
Who cannot join
- No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
- No other active systemic malignancies treated with chemotherapy within the last 12 months.
- Must not have received previous chemotherapy (except hydroxyurea) for AML.
- Must not have significantly abnormal kidney or liver disease.
- Must not have known human immunodeficiency virus (HIV).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Tower Cancer Research Foundation
Beverly Hills, California, 90210
Billings Clinic Cancer Research
Billings, Montana, 59101
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Glendale Memorial Hospital
Glendale, California, 91204
Cancer Centers of the Carolinas
Greenville, South Carolina, 29601
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Joliet Oncology-Hematology Associates
Joliet, Illinois, 60435
Gunderson Clinic
La Crosse, Wisconsin, 54601
Northshore University Hospital, Monter Cancer Center
Lake Success, New York, 11042
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Michigan State University, Breslin Cancer Center
Lansing, Michigan, 48910
Kenmar Research Institute
Los Angeles, California, 90057
University of California Los Angeles
Los Angeles, California, 90095-1678
Southern Cancer Center
Mobile, Alabama, 36608
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
Bay Area Cancer Research Group
Pleasant Hill, California, 94523
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML
The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Lintuzumab (SGN-33), Low dose cytarabine, Placebo
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Hematologic Diseases, Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Hematologic Diseases, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lintuzumab (SGN-33)Drug
Also called SGN-33
600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.
Low dose cytarabineDrug
Also called Ara-C, Cytosar
20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
PlaceboDrug
IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lintuzumab plus low dose cytarabine Receives: Drug: Lintuzumab (SGN-33); Drug: Low dose cytarabine |
| 2 | Active comparator | Placebo plus low dose cytarabine Receives: Drug: Low dose cytarabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 12 months
Secondary outcomes (1)
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2010
- Study completionAug 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sievers, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528333
- Sponsor's protocol ID
- SG033-0003
- Status last verified
- Dec 2014
- First submitted
- 10 Sep 2007
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.
PubMed 22801961
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML
- ClinicalTrials.gov ID
- NCT00528333
- Acronym / sponsor ID
- SG033-0003
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Hematologic Diseases, Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Sep 2007 (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 purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lintuzumab (SGN-33), Drug: Low dose cytarabineLintuzumab plus low dose cytarabine |
| 2 | Active comparator | Drug: Low dose cytarabine, Drug: PlaceboPlacebo plus low dose cytarabine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
- After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
- At least 20% blasts in blood or marrow.
- Must have a minimum of 50% leukemic blasts that express CD33.
- ECOG performance status score of 0 to 2.
Key exclusion criteria (5 listed)
- No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
- No other active systemic malignancies treated with chemotherapy within the last 12 months.
- Must not have received previous chemotherapy (except hydroxyurea) for AML.
- Must not have significantly abnormal kidney or liver disease.
- Must not have known human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Lintuzumab (SGN-33)Also: SGN-33600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles. | Drug | 1 |
| Low dose cytarabineAlso: Ara-C, Cytosar20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles. | Drug | 1, 2 |
| PlaceboIV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles | Drug | 2 |
Primary outcome
Overall survival
Time frame: 12 months
1 secondary outcome
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
Time frame: 13 months
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 7 Jan 2015.
- Results publication: PubMed 22801961Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.
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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.
Eric Sievers, MD study director
Seagen Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lintuzumab (SGN-33) and Low dose cytarabine in people with Acute Myeloid Leukemia, run by Seagen Inc. at 20 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 5 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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?
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?
Overall survival (time frame: 12 months). 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 NCT00528333, 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 7 Jan 2015.