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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03616470




Registration number
NCT03616470
Ethics application status
Date submitted
26/07/2018
Date registered
6/08/2018
Date last updated
5/08/2019

Titles & IDs
Public title
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Scientific title
A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Secondary ID [1] 0 0
GMI-1271-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Uproleselan
Treatment: Drugs - Placebo

Experimental: Uproleselan (GMI-1271) - Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride) - Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)


Treatment: Drugs: Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin

Treatment: Drugs: Placebo
Saline, 0.9% Sodium Chloride

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival - Time from the date of randomization into the study to the date of death.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Rate of severe oral mucositis - Incidence of severe oral mucositis experienced in patients after treatment.
Timepoint [1] 0 0
up to 60 days
Secondary outcome [2] 0 0
Overall response rate - Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
Timepoint [2] 0 0
Up to 60 days

Eligibility
Key inclusion criteria
- =18 years and =75 years in age

- Patients with relapsed or refractory AML

- No more than one prior stem cell transplant

- Has not received the chemotherapy regimen to be used for induction on this trial

- Is considered medically eligible to receive the chemotherapy regimen to be used for
induction on this trial
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage
(biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or
secondary refractory AML.

- Active signs or symptoms of CNS involvement by malignancy.

- Stem cell transplantation =4 months prior to dosing.

- Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other
experimental therapy or chemotherapy within 14 days of dosing.

- Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

- Inadequate organ function.

- Abnormal liver function.

- Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

- Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

- Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

- Clinically significant cardiovascular disease.

- Major surgery within 4 weeks of dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,PerthQLD,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Townsville Hospital - Douglas
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Cancer Clinical Trials Centre (CCTC) - Heidelberg
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Ireland
State/province [11] 0 0
Galway
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlycoMimetics Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin
antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to
chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be
investigated in patients with relapsed/refractory AML
Trial website
https://clinicaltrials.gov/show/NCT03616470
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel J DeAngelo, MD, PhD
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GlycoMimetics, Inc.
Address 0 0
Country 0 0
Phone 0 0
240-243-1201
Fax 0 0
Email 0 0
clinicaltrials@glycomimetics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03616470