Acute Myeloid LeukemiaNCT00161668
Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care
An observational study of Acute Myeloid Leukemia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 59 sites in United States.
Trial summary
This study is designed to assess the safety of Mylotarg therapy in routine practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Mylotarg
- How many people
- 500 participants
- Where
- 59 sitesUnited States
- Study dates
- Oct 2001to not given
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated by Mylotarg
- Provide ICF
Who cannot join
None listed.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Study site
Akron, Ohio, 44302
Study site
Albuquerque, New Mexico, 87109
Study site
Ann Arbor, Michigan, 48109-0999
Study site
Appleton, Wisconsin, 54911
Study site
Arlington, Virginia, 22205
Study site
Berkely, California, 94704
Study site
Bismarck, North Dakota, 58501
Study site
Boynton Beach, Florida, 33435
Study site
Buffalo, New York, 14263
Study site
Burbank, California, 91505
Study site
Canton, Ohio, 44718
Study site
Charleston, West Virginia, 25304
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612-3838
Study site
Chicago, Illinois, 60612-7323
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45236
Study site
Cleveland, Ohio, 44195
Study site
Columbia, Missouri, 65203
Study site
Concord, California, 94520
Study site
Denver, Colorado, 80218
Study site
Durham, North Carolina, 27705
Study site
Grand Rapids, Michigan, 49503
Study site
Hershey, Pennsylvania, 17033-0850
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Iowa City, Iowa, 52242
Study site
Kalamazoo, Michigan, 49007-3731
Study site
Kalamazoo, Michigan, 49048
Study site
Lexington, Kentucky, 40536-0093
Study site
Loma Linda, California, 92354
Study site
Los Angeles, California, 90095-1678
Study site
Louisville, Kentucky, 40202
Study site
Memphis, Tennessee, 38120
Study site
Morgantown, West Virginia, 26506-9162
Study site
Nashville, Tennessee, 37205
Study site
Nashville, Tennessee, 37232-5505
Study site
Neptune City, New Jersey, 07754
Study site
New Hyde Park, New York, 11040
Study site
New York, New York, 10019
Study site
New York, New York, 10032
Study site
Oklahoma City, Oklahoma, 72112
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15224
Study site
Plantation, Florida, 33324
Study site
Portland, Oregon, 97201
Study site
Richmond, Virginia, 23298-0157
Study site
San Francisco, California, 94143
Study site
Shrevport, Louisiana, 71130-3932
Study site
St Louis, Missouri, 63141
Study site
Stuart, Florida, 34994
Study site
Sylmar, California, 91342
Study site
Tamarac, Florida, 33321
Study site
Temple, Texas, 76508
Study site
The Bronx, New York, 10466
Study site
Tucson, Arizona, 85404
Study site
Valhalla, New York, 10595
Study site
Winston-Salem, North Carolina, 27106
About this study
Official title: Prospective Observational Study of Mylotarg (Gemtuzumab Ozogamicin) in Usual Care
This study is designed to assess the safety of Mylotarg therapy in routine practice.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Mylotarg
- Keywords
- Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MylotargDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161668
- Sponsor's protocol ID
- 0903X-100847
- Status last verified
- Mar 2007
- First submitted
- 8 Sep 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Mylotarg (Gemtuzumab Ozogamicin) in Usual Care
- ClinicalTrials.gov ID
- NCT00161668
- Acronym / sponsor ID
- 0903X-100847
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- First posted
- 12 Sep 2005 (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 designed to assess the safety of Mylotarg therapy in routine practice.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated by Mylotarg
- Provide ICF
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mylotarg | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Mar 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 59 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 0 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 15 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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.
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.
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 15 Mar 2007.