Acute Myeloid LeukemiaPhase 1NCT00283114
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
A Phase 1 study testing lintuzumab in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Seagen Inc. at 9 sites in United States.
Trial summary
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders
- What is being tested?
- lintuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2005to Jan 2010
- 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
- Patients must have a diagnosis of MDS or AML.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
Who cannot join
- Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
- Patients with a prior allogeneic transplant.
- Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
- Patients receiving chemotherapy within the last four weeks.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Cancer Center of the Carolinas
Greenville, South Carolina, 29605
Indiana Oncology-Hematology Consultants
Indianapolis, Indiana, 46107
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10021
Scott & White Memorial Hospital
Temple, Texas, 76508
University of Massachusetts Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia
- Being tested
- lintuzumab
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases, Myeloproliferative Disorders, Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Myelomonocytic, Chronic, Hematologic Diseases, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lintuzumabDrug
Also called SGN-33
1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: lintuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events and lab abnormalities.
Measured: 13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Measured: 13 months
Antitumor activity.
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 posted27 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionJan 2010
- Study completionJan 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sievers, M.D., Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283114
- Sponsor's protocol ID
- SG033-0001
- Status last verified
- Dec 2014
- First submitted
- 25 Jan 2006
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.
PubMed 19557623
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00283114
- Acronym / sponsor ID
- SG033-0001
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases, Myeloproliferative Disorders, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Jan 2006 (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.
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lintuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a diagnosis of MDS or AML.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
Key exclusion criteria (4 listed)
- Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
- Patients with a prior allogeneic transplant.
- Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
- Patients receiving chemotherapy within the last four weeks.
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 |
|---|---|---|
| lintuzumabAlso: SGN-331.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles | Drug | 1 |
Primary outcome
The incidence of adverse events and lab abnormalities.
Time frame: 13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Time frame: 13 months
Antitumor activity.
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 18 Dec 2014.
- Results publication: PubMed 19557623Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.
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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, M.D. study director
Seagen Inc.
9 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 lintuzumab in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Seagen Inc. at 9 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 2 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The incidence of adverse events and lab abnormalities. (time frame: 13 months). 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 NCT00283114, 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 18 Dec 2014.