Acute Myeloid LeukemiaNCT04678466
Flotetuzumab Expanded Access Program
A study testing flotetuzumab in people with Acute Myeloid Leukemia and AML, run by MacroGenics.
Trial summary
The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, AML, AML, Adult Recurrent
- What is being tested?
- flotetuzumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Weight of at least 17 kilograms
- CD123-positive hematologic malignancy
- Adequate organ reserve
- Provider and site are trained on study protocol using flotetuzumab
Who cannot join
- AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
- Primary induction failure
- Early relapse (less than 6 months after first complete remission )
- Three prior lines of therapy, including maximum of 1 prior salvage attempts
About this study
Official title: An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
Read the detailed description
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.
- Conditions
- Acute Myeloid Leukemia, AML, AML, Adult Recurrent
- Being tested
- flotetuzumab
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flotetuzumabBiological
Also called MGD006
CD123 x CD3 bispecific DART® antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Ward, MD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678466
- Sponsor's protocol ID
- MGD006-EA
- Status last verified
- May 2022
- First submitted
- 16 Dec 2020
- Last updated
- 31 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
- ClinicalTrials.gov ID
- NCT04678466
- Acronym / sponsor ID
- MGD006-EA
- Conditions
- Acute Myeloid Leukemia, AML, AML, Adult Recurrent
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- First posted
- 22 Dec 2020 (actual)
- 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.
The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
Detailed description
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Weight of at least 17 kilograms
- CD123-positive hematologic malignancy
- Adequate organ reserve
- Provider and site are trained on study protocol using flotetuzumab
Key exclusion criteria (4 listed)
- AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
- Primary induction failure
- Early relapse (less than 6 months after first complete remission )
- Three prior lines of therapy, including maximum of 1 prior salvage attempts
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 |
|---|---|---|
| flotetuzumabAlso: MGD006CD123 x CD3 bispecific DART® antibody | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Ashley Ward, MD study director
MacroGenics
Questions about this trial
What is this clinical trial studying?
A study testing flotetuzumab in people with Acute Myeloid Leukemia and AML, run by MacroGenics.
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: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 31 May 2022.