Acute Myeloid LeukemiaPhase 1/2NCT00766116
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
A Phase 1/2 study testing 5-Azacitidine and Gemtuzumab ozogamicin in people with Acute Myeloid Leukemia, run by University of California, San Diego at 3 sites in United States.
Trial summary
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- 5-Azacitidine and Gemtuzumab ozogamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2005to 26 Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Relapsed AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
- ≥ 18 years old
- Previously untreated for current AML relapse
- Adequate organ function
- Written informed consent
Who cannot join
- Pregnant or breast-feeding women
- Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
- Currently receiving another investigational drug
- Currently receiving other anti-cancer agents
- Uncontrolled infection
- HIV positive
- Received previous therapy with either Mylotarg or 5-azacitidine
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northside Hospital/BMTGA
Atlanta, Georgia, 30342
UCSD Moores Cancer Center
La Jolla, California, 92093
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
Read the detailed description
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- 5-Azacitidine, Gemtuzumab ozogamicin
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-AzacitidineDrug
Also called Vidaz
Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
Gemtuzumab ozogamicinDrug
Also called Mylotarg
Mylotarg given 2 times over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Level 1 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2 Receives: Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin |
| Phase 1 Dose Level 2 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin
75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2 Receives: Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin |
| Phase I Dose Level 3 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 Receives: Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin |
| Phase 2 Dose Level 1 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 Receives: Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities
MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.
Measured: up to 28 days
Secondary outcomes (1)
Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine
Measured: Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJul 2005
- Primary completion26 Sep 2014
- Study completion26 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Pfizer
- Responsible party
- Principal investigator, Edward Ball, University of California, San Diego
- Investigators
- Edward D Ball, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766116
- Sponsor's protocol ID
- 090516
- Status last verified
- Jan 2019
- First submitted
- 2 Oct 2008
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
- ClinicalTrials.gov ID
- NCT00766116
- Acronym / sponsor ID
- 090516
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Celgene Corporation, Pfizer
- Study start
- Jul 2005 (actual)
- Primary completion
- 26 Sep 2014 (actual)
- Study completion
- 26 Sep 2014 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
Detailed description
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Level 1 | Experimental | Drug: 5-Azacitidine, Drug: Gemtuzumab ozogamicin5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2 |
| Phase 1 Dose Level 2 | Experimental | Drug: 5-Azacitidine, Drug: Gemtuzumab ozogamicin5-Azacitidine, Gemtuzumab ozogamicin 75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2 |
| Phase I Dose Level 3 | Experimental | Drug: 5-Azacitidine, Drug: Gemtuzumab ozogamicin5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 |
| Phase 2 Dose Level 1 | Experimental | Drug: 5-Azacitidine, Drug: Gemtuzumab ozogamicin5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Relapsed AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
- ≥ 18 years old
- Previously untreated for current AML relapse
- Adequate organ function
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women
- Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
- Currently receiving another investigational drug
- Currently receiving other anti-cancer agents
- Uncontrolled infection
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 |
|---|---|---|
| 5-AzacitidineAlso: VidazGiven in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit. | Drug | Phase 1 Dose Level 1, Phase 1 Dose Level 2, Phase 2 Dose Level 1, Phase I Dose Level 3 |
| Gemtuzumab ozogamicinAlso: MylotargMylotarg given 2 times over 2 weeks | Drug | Phase 1 Dose Level 1, Phase 1 Dose Level 2, Phase 2 Dose Level 1, Phase I Dose Level 3 |
Primary outcome
Number of Participants With Dose Limiting Toxicities
Time frame: up to 28 days
MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.
1 secondary outcome
Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine
Time frame: Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edward D Ball, MD principal investigator
UCSD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5-Azacitidine and Gemtuzumab ozogamicin in people with Acute Myeloid Leukemia, run by University of California, San Diego at 3 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 7 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose Limiting Toxicities (time frame: up to 28 days). 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 18 Feb 2019.