Leukemia, Myeloid, AcutePhase 1/2NCT02306291
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
A Phase 1/2 study testing GMI-1271, Mitoxantrone and Etoposide in people with Leukemia, Myeloid, Acute, run by GlycoMimetics Incorporated at 8 sites in 3 countries.
Trial summary
This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- GMI-1271, Mitoxantrone and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Mar 2015to May 2018
- Phase
- Phase 1/2
- 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
Who may be able to join
- AML (including secondary AML) diagnosed as per WHO criteria
- For relapsed/refractory subjects only:
- Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines
- Medically eligible to receive MEC
- Absolute blast count (ABC) ≤ 40,000/mm
- For treatment-naïve subjects only:
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- Subjects ≥ 60 years of age with newly diagnosed AML
- Medically eligible to receive "7+3" cytarabine/idarubicin
- ABC count ≤ 40,000/mm
- ECOG performance status 0-2
- Hemodynamically stable and adequate organ function
Who cannot join
- Acute promyelocytic leukemia
- Acute leukemia of ambiguous lineage (biphenotypic leukemia)
- Active signs or symptoms of CNS involvement by malignancy
- No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
- Known history or evidence of active hepatitis A, B, or C or HIV
- Uncontrolled acute life threatening bacterial, viral or fungal infection
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- Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
- Hematopoietic stem cell transplantation ≤ 4 months of dosing
- Clinically significant cardiovascular disease
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
University of Rochester
Rochester, New York, 14642
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of Washington
Seattle, Washington, 98109
About this study
Official title: A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia
This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- GMI-1271, Mitoxantrone, Etoposide, Cytarabine, Idarubicin
- Keywords
- AML, Acute myeloid leukemia, E-selectin, relapse refractory, elderly newly diagnosed, induction
- 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.
GMI-1271Drug
Also called Uproleselan
E-selectin antagonist
MitoxantroneDrug
induction chemotherapy
EtoposideDrug
induction chemotherapy
CytarabineDrug
induction chemotherapy
IdarubicinDrug
induction chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Phase I) | Experimental | GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Receives: Drug: GMI-1271; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Arm B (Phase II Arm A) | Experimental | GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Receives: Drug: GMI-1271; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Arm C (Phase II Arm B) | Experimental | GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older Receives: Drug: GMI-1271; Drug: Cytarabine; Drug: Idarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by frequency, severity and relatedness of adverse events
Measured: up to 44 days
Secondary outcomes (6)
Time versus plasma concentration profile of GMI-1271
Plasma concentration of GMI-1271
Measured: up to 11 days
Overall response rate
Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment
Measured: up to 12 months
Time to response
Time from date of first dose to first documentation of response
Measured: up to 12 months
Duration of response
Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first
Measured: up to 12 months
Event-free survival
Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first
Measured: up to 12 months
Overall survival
The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel DeAngelo, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306291
- Sponsor's protocol ID
- GMI-1271-201
- Status last verified
- May 2019
- First submitted
- 1 Dec 2014
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeAngelo DJ, Jonas BA, Liesveld JL, Bixby DL, Advani AS, Marlton P, Magnani JL, Thackray HM, Feldman EJ, O'Dwyer ME, Becker PS. Phase 1/2 study of uproleselan added to chemotherapy in patients with relapsed or refractory acute myeloid leukemia. Blood. 2022 Feb 24;139(8):1135-1146. doi: 10.1182/blood.2021010721.
PubMed 34543383
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02306291
- Acronym / sponsor ID
- GMI-1271-201
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- AML, Acute myeloid leukemia, E-selectin, relapse refractory, elderly newly diagnosed, induction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Dec 2014 (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 will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Phase I) | Experimental | Drug: GMI-1271, Drug: Mitoxantrone, Drug: Etoposide, Drug: CytarabineGMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older |
| Arm B (Phase II Arm A) | Experimental | Drug: GMI-1271, Drug: Mitoxantrone, Drug: Etoposide, Drug: CytarabineGMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older |
| Arm C (Phase II Arm B) | Experimental | Drug: GMI-1271, Drug: Cytarabine, Drug: IdarubicinGMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- AML (including secondary AML) diagnosed as per WHO criteria
- For relapsed/refractory subjects only:
- For treatment-naïve subjects only:
- ECOG performance status 0-2
- Hemodynamically stable and adequate organ function
Key exclusion criteria (9 listed)
- Acute promyelocytic leukemia
- Acute leukemia of ambiguous lineage (biphenotypic leukemia)
- Active signs or symptoms of CNS involvement by malignancy
- No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
- Known history or evidence of active hepatitis A, B, or C or HIV
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 |
|---|---|---|
| GMI-1271Also: UproleselanE-selectin antagonist | Drug | Arm A (Phase I), Arm B (Phase II Arm A), Arm C (Phase II Arm B) |
| Mitoxantroneinduction chemotherapy | Drug | Arm A (Phase I), Arm B (Phase II Arm A) |
| Etoposideinduction chemotherapy | Drug | Arm A (Phase I), Arm B (Phase II Arm A) |
| Cytarabineinduction chemotherapy | Drug | Arm A (Phase I), Arm B (Phase II Arm A), Arm C (Phase II Arm B) |
| Idarubicininduction chemotherapy | Drug | Arm C (Phase II Arm B) |
Primary outcome
Safety assessed by frequency, severity and relatedness of adverse events
Time frame: up to 44 days
6 secondary outcomes
Time versus plasma concentration profile of GMI-1271
Time frame: up to 11 days
Overall response rate
Time frame: up to 12 months
Time to response
Time frame: up to 12 months
Duration of response
Time frame: up to 12 months
Event-free survival
Time frame: up to 12 months
Overall survival
Time frame: up to 12 months
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 17 May 2019.
- Derived from this study: PubMed 34543383DeAngelo DJ, Jonas BA, Liesveld JL, Bixby DL, Advani AS, Marlton P, Magnani JL, Thackray HM, Feldman EJ, O'Dwyer ME, Becker PS. Phase 1/2 study of uproleselan added to chemotherapy in patients with relapsed or refractory acute myeloid leukemia. Blood. 2022 Feb 24;139(8):1135-1146. doi: 10.1182/blood.2021010721.
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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.
Daniel DeAngelo, MD, PhD principal investigator
Dana-Farber Cancer Institute
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GMI-1271, Mitoxantrone and Etoposide in people with Leukemia, Myeloid, Acute, run by GlycoMimetics Incorporated at 8 sites in 3 countries.
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 11 inclusion and 9 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 17 May 2019. 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, Australia, Ireland. 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?
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?
Safety assessed by frequency, severity and relatedness of adverse events (time frame: up to 44 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306291, which also lists 1 linked publication.
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 17 May 2019.