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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02306291




Registration number
NCT02306291
Ethics application status
Date submitted
1/12/2014
Date registered
3/12/2014
Date last updated
17/05/2019

Titles & IDs
Public title
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Scientific 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
Secondary ID [1] 0 0
GMI-1271-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 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 - GMI-1271
Treatment: Drugs - Mitoxantrone
Treatment: Drugs - Etoposide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Idarubicin

Experimental: Arm A (Phase I) - GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older

Experimental: Arm B (Phase II Arm A) - GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older

Experimental: Arm C (Phase II Arm B) - GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older


Treatment: Drugs: GMI-1271
E-selectin antagonist

Treatment: Drugs: Mitoxantrone
induction chemotherapy

Treatment: Drugs: Etoposide
induction chemotherapy

Treatment: Drugs: Cytarabine
induction chemotherapy

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

Outcomes
Primary outcome [1] 0 0
Safety assessed by frequency, severity and relatedness of adverse events
Timepoint [1] 0 0
up to 44 days
Secondary outcome [1] 0 0
Time versus plasma concentration profile of GMI-1271
Timepoint [1] 0 0
up to 11 days
Secondary outcome [2] 0 0
Overall response rate
Timepoint [2] 0 0
up to 12 months
Secondary outcome [3] 0 0
Time to response
Timepoint [3] 0 0
up to 12 months
Secondary outcome [4] 0 0
Duration of response
Timepoint [4] 0 0
up to 12 months
Secondary outcome [5] 0 0
Event-free survival
Timepoint [5] 0 0
up to 12 months
Secondary outcome [6] 0 0
Overall survival
Timepoint [6] 0 0
up to 12 months

Eligibility
Key inclusion criteria
Inclusion criteria:

1. AML (including secondary AML) diagnosed as per WHO criteria

2. 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

3. For treatment-naïve subjects only:

- Subjects = 60 years of age with newly diagnosed AML

- Medically eligible to receive "7+3" cytarabine/idarubicin

- ABC count = 40,000/mm

4. ECOG performance status 0-2

5. Hemodynamically stable and adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Acute promyelocytic leukemia

2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)

3. Active signs or symptoms of CNS involvement by malignancy

4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing

5. Known history or evidence of active hepatitis A, B, or C or HIV

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

7. Active graft versus host disease (GVHD) = Grade 2 or extensive chronic GVHD requiring
immunosuppressive therapy

8. Hematopoietic stem cell transplantation = 4 months of dosing

9. Clinically significant cardiovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
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
Michigan
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
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Ireland
State/province [7] 0 0
Galway

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 GMI-1271, a specific E-selectin antagonist, in acute myeloid
leukemia in combination with standard agents used to treat this disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02306291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02306291