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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-001076-38
    Sponsor's Protocol Code Number:GMI-1271-301
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001076-38
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to determine the efficacy of Uproleselan when given in
    addition to anti-cancer drugs in adults with a type of cancer called acute
    myeloid leukemia
    A.4.1Sponsor's protocol code numberGMI-1271-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03616470
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlycoMimetics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlycoMimetics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlycoMimetics Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address9708 Medical Center Drive
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@glycomimetics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/010/17
    D.3 Description of the IMP
    D.3.1Product nameUproleselan
    D.3.2Product code GMI-1271
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUproleselan
    D.3.9.1CAS number 1914993-95-5
    D.3.9.2Current sponsor codeGMI-1271
    D.3.9.3Other descriptive nameSODIUM (1R, 3R, 4R, 5S)-3-({2-N-ACETYLAMINO-2-DEOXY-3-O-[(1S)-1-CARBOXYLATO-2-CYCLOHEXYLETHYL]-Β-D-GALACTOPYRANOSYL}OXY)-4-({6-DEOXY-Α-LGALACTOPYRANOSYL}OXY)-5-ETHYL-CYCLOHEXAN-1-YL-(38-OXO-2,5,8,11,14,17,20,23,26,29,32,35-DODECAOXA-39-AZAHENTETRACONTAN-41-YL) CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB169194
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    A blood cancer called Acute Myeloid Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to compare overall survival (OS) achieved with uproleselan administered with chemotherapy versus chemotherapy alone.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of this trial are as follows:
    • To compare the incidence of severe oral mucositis with onset during the induction period with uproleselan administered with chemotherapy versus chemotherapy alone.
    • To compare the remission rate (complete remission [CR]/complete remission with partial count recovery [CRh]) achieved with uproleselan administered with chemotherapy versus chemotherapy alone.
    • To compare the CR rate achieved with uproleselan administered with chemotherapy versus chemotherapy alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for the trial:
    1. ≥18 years and ≤75 years in age.
    2. AML diagnosed with >20% myeloid marrow blasts per WHO criteria at the time of initial diagnosis as per local analysis report.
    3. For subjects with primary refractory AML:
    a. Refractory disease is defined as persistent disease (≥5% blasts in the bone marrow) at least 28 days after initiation of induction therapy or relapse from a first remission (CR, CRi, complete remission with incomplete platelet recovery [CRp]) lasting for <90 days. Isolated extramedullary disease is not allowed.
    b. Must have received 1 (and only 1) prior induction regimen containing both an anthracycline and cytarabine. Except as defined below, a second induction with intent to induce remission is not allowed.
    i. Re-induction within 28 days with a comparable regimen containing the same chemotherapy agents (e.g., cytarabine/daunorubicin ‘7+3’ and ‘5+2’; or cytarabine/daunorubicin ‘7+3’ and ‘7+3’) is allowed.
    ii. Re-induction within 28 days with a comparable regimen using an alternative anthracycline (e.g., cytarabine/daunorubicin in the first induction and cytarabine/idarubicin in the second) is allowed.
    4. For subjects with relapsed AML, must be in first or second untreated relapse.
    a. Relapsed disease is defined as having ≥5% blasts in the bone marrow after having achieved previous CR, CRi, or CRp by ELN Response Criteria and remission lasted for ≥90 days. Isolated extramedullary disease is not allowed.
    b. Any cytotoxic or non-cytotoxic regimen used with the intent to induce remission, regardless of the agents used, will be counted as an induction attempt towards this assessment of untreated relapse. For example: anthracycline-based, cytarabine-based, clofarabine-based, cladribine-based, hypomethylating agent regimens, and antibody-drug
    conjugates.
    c. Single agent FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors are not considered cytotoxic chemotherapy for the purposes of this assessment and are allowed.
    5. One prior HSCT is allowed.
    6. Has not received the chemotherapy regimen to be used for induction on this trial.
    a. For example, a subject who received MEC previously could receive FAI, but not MEC, on this trial.
    7. Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial.
    8. Peripheral absolute blast count (ABC) ≤40.0 x 109/L (ABC = total white blood cells [WBC] x blast % in peripheral blood) Hydroxyurea to control absolute blast count is allowed.
    9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    10. Estimated life expectancy >4 weeks.
    11. Written informed consent provided in accordance with federal, local, and institutional guidelines.
    12. Willing and able to participate in all required evaluations and procedures in this trial protocol.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must be excluded:
    1. Acute promyelocytic leukemia.
    2. Acute leukemia of ambiguous lineage (biphenotypic leukemia).
    3. Chronic myeloid leukemia with myeloid blast crisis.
    4. Secondary refractory AML.
    a. Any cytotoxic or non-cytotoxic regimen used with the intent to induce remission.
    b. Single agent FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors are allowed.
    5. Prior enrollment in this clinical trial.
    6. Active signs or symptoms of CNS involvement by malignancy.
    7. Prior G-CSF, granulocyte macrophage-colony stimulating factor (GM-CSF) or plerixafor within 7 days of uproleselan/placebo dosing.
    8. HSCT ≤ 4 months prior to uproleselan/placebo dosing.
    9. GVHD ≥ Grade 2 or active chronic GVHD requiring immunosuppressive therapy. Graft versus host disease prophylaxis in the absence of chronic GVHD must be discontinued at least 14 days before uproleselan/placebo dosing.
    10. Any immunotherapy or radiotherapy therapy within 28 days of uproleselan/placebo dosing;
    any other experimental therapy or chemotherapy within 14 days of dosing:
    a. with the exception of hydroxyurea, which may be used to control peripheral blast count prior to uproleselan/placebo dosing; AND
    b. FLT3 inhibitors, TKI, or IDH1/IDH2 inhibitors, or similar targeted inhibitors. Such agents must be
    discontinued 5 days before uproleselan/placebo dosing.
    11. Abnormal liver function. Confirm within 72 hours of randomization:
    a. ALT and/or AST > 2.5x ULN.
    b. Direct bilirubin > 2.0x ULN.
    c. Unless due to underlying malignancy.
    12. Creatinine clearance <45 mL/min or creatinine >1.5x ULN. Confirm within 72 hours of randomization.
    13. Known active infection with hepatitis A, B (e.g. HBsAg positive), or C (e.g. anti-HCV positive), or human immunodeficiency virus.
    14. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
    15. Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject has current significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hemodynamic instability, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
    16. Major surgery within 4 weeks before uproleselan/placebo dosing.
    17. Previous or concurrent malignancy with the exception of:
    a. Adequately treated basal or squamous cell carcinoma, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast.
    b. Localized prostate cancer definitively treated with surgery or radiation; or stable on hormone therapy.
    c. Other cancer from which the subject has been disease free for at least 2 years.
    18. Any medical, psychiatric, or other condition which, in the opinion of the investigator, unfavorably alters the risk-benefit of subject participation, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
    19. Pregnant or nursing (lactating).
    20. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the trial and for 3 months after the last dose of uproleselan/placebo. Women who are postmenopausal with amenorrhea for at least 1 year prior to trial entry and follicle stimulating hormone (FSH)
    serum levels consistent with postmenopausal status (> 28U/L) will be considered NOT of
    child-bearing potential. Highly effective contraception includes:
    a. Total abstinence with a male partner.
    b. Female sterilization (has had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before uproleselan/placebo. In case of oophorectomy alone, the subject would be eligible only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    c. Male sterilization (at least 6 months prior to Screening). For female subjects on the trial, the vasectomized male partner should be the sole partner for that subject.
    d. BOTH of the following forms of contraception consistently used together:
    i. Injected, transdermal, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%) with the exception of intrauterine devices, which are excluded due to the risk of infection and bleeding.
    ii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    21. Men who are sexually active and not willing to use condoms during the trial and for 3 months after the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival compared between the treatment groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Individual subjects will be followed until death.
    E.5.2Secondary end point(s)
    • Incidence of severe oral mucositis during the induction period
    • Remission rate (CR/CRh)
    • Complete remission (CR) rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Subjects will be actively monitored for oral mucositis at Baseline, then Day 2 prior to chemotherapy, and continue every 3-4 days (i.e., twice weekly) while in the hospital and once weekly (every 7 ± 2 days) while outpatient during the induction period
    •Disease response assessment will be done within 7 days of counts recovering, as early as 21 days after the first dose of induction chemotherapy, prior to subsequent therapy ,or by 60 days after the first dose of chemotherapy if bone marrow otherwise indicates remission and counts have not recovered.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 380
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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