Myelodysplastic Syndrome (MDS)Phase 1NCT00502112
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
A Phase 1 study testing lintuzumab and lenalidomide in people with Myelodysplastic Syndrome (MDS), run by Seagen Inc. at 8 sites in United States.
Trial summary
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- lintuzumab and lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2008to May 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
- Disease confirmation of MDS.
- Between 5% and 30% blasts in the bone marrow.
- Received treatment for cytopenias within 2-months
- ECOG ≤ 2.
Who cannot join
- Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
- Received chemotherapy/radiotherapy within 4 weeks of study registration.
- Received prior bone marrow transplant.
- 5q- chromosomal deletion in malignant cells.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Georgia Cancer Specialists
Atlanta, Georgia, 30342
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Ohio State University
Columbus, Ohio, 43210
Rocky Mountain Cancer Center
Denver, Colorado, 80218
St.Vincent's Comprehensive Cancer Center
New York, New York, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- lintuzumab, lenalidomide
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
- Medical subject headings
- Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lintuzumabDrug
Also called SGN-33
4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
lenalidomideDrug
Also called Revlimid
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lintuzumab and lenalidomide Receives: Drug: lintuzumab; Drug: lenalidomide |
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: 1 month after last dose
Secondary outcomes (2)
Antitumor activity
Measured: Every other 21-day cycle
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
Measured: 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies 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
- 13 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
- NCT00502112
- Sponsor's protocol ID
- SG033-0002
- Status last verified
- Oct 2011
- First submitted
- 13 Jul 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT00502112
- Acronym / sponsor ID
- SG033-0002
- Conditions
- Myelodysplastic Syndrome (MDS)
- Keywords
- Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Jul 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.
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.
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, Drug: lenalidomidelintuzumab and lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Disease confirmation of MDS.
- Between 5% and 30% blasts in the bone marrow.
- Received treatment for cytopenias within 2-months
- ECOG ≤ 2.
Key exclusion criteria (4 listed)
- Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
- Received chemotherapy/radiotherapy within 4 weeks of study registration.
- Received prior bone marrow transplant.
- 5q- chromosomal deletion in malignant cells.
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-334 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle | Drug | 1 |
| lenalidomideAlso: Revlimid10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle | Drug | 1 |
Primary outcome
The incidence of adverse events and lab abnormalities
Time frame: 1 month after last dose
2 secondary outcomes
Antitumor activity
Time frame: Every other 21-day cycle
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
Time frame: 1 month after last dose
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 12 Oct 2011.
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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.
8 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 and lenalidomide in people with Myelodysplastic Syndrome (MDS), run by Seagen Inc. at 8 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 4 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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: 1 month after last dose). 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 Oct 2011.