LeukemiaPhase 2NCT00003131
CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
A Phase 2 study testing chemotherapy and gemtuzumab ozogamicin in people with Leukemia, run by Pfizer at 13 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- chemotherapy and gemtuzumab ozogamicin
- How many people
- 55 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 1997to Feb 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically diagnosed CD33 positive acute myeloid leukemia (AML) in first relapse At least 6 months of complete remission No CNS leukemia No AML secondary to exposure to chemotherapy or toxins
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Fertile patients must use an effective method of contraception Not known to be HIV positive No prior myelodysplastic syndrome No other active malignancy No uncontrolled infections Able to obtain bone marrow aspirate
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No prior anti-CD33 antibody therapy Chemotherapy: No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
New England Medical Center Hospital
Boston, Massachusetts, 02111
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Beckman Research Institute, City of Hope
Duarte, California, 91010
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse.
Read the detailed description
OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.
OUTLINE: This is an open label, single arm, multicenter study. Patients receive CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.
PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.
- Conditions
- Leukemia
- Being tested
- chemotherapy, gemtuzumab ozogamicin
- Keywords
- recurrent adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
gemtuzumab ozogamicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2004 (estimated)
- Study startFeb 1997
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Stanley Berger, MD, Study chair, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003131
- Sponsor's protocol ID
- W-AR-0903B1-201-US
- Other IDs
- CDR0000065896, UCCRC-8600, NCI-V97-1355
- Status last verified
- Aug 2012
- First submitted
- 1 Nov 1999
- Last updated
- 22 Aug 2012
- Results posted
- No
Publications
Lang K, Menzin J, Earle CC, Mallick R. Outcomes in patients treated with gemtuzumab ozogamicin for relapsed acute myelogenous leukemia. Am J Health Syst Pharm. 2002 May 15;59(10):941-8. doi: 10.1093/ajhp/59.10.941.
PubMed 12040733Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5.
PubMed 30062662
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
- ClinicalTrials.gov ID
- NCT00003131
- Acronym / sponsor ID
- W-AR-0903B1-201-US
- Conditions
- Leukemia
- Keywords
- recurrent adult acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 1997
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 24 Aug 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse.
Detailed description
OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.
OUTLINE: This is an open label, single arm, multicenter study. Patients receive CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.
PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| chemotherapy | Drug | – |
| gemtuzumab ozogamicin | 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 22 Aug 2012.
- Background: PubMed 12040733Lang K, Menzin J, Earle CC, Mallick R. Outcomes in patients treated with gemtuzumab ozogamicin for relapsed acute myelogenous leukemia. Am J Health Syst Pharm. 2002 May 15;59(10):941-8. doi: 10.1093/ajhp/59.10.941.
- Derived from this study: PubMed 30062662Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5.
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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.
Mark Stanley Berger, MD study chair
Wyeth is now a wholly owned subsidiary of Pfizer
13 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 chemotherapy and gemtuzumab ozogamicin in people with Leukemia, run by Pfizer at 13 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?
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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003131, which also lists 2 linked publications.
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 22 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.