Acute Myeloid Leukemia MedDRA version: 21.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
GlycoMimetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The most important inclusion criteria are:: • =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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: The most important exclusion criteria are: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to compare overall survival (OS) achieved with uproleselan administered with chemotherapy versus chemotherapy alone.;Secondary Objective: 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 CR rate achieved 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. ;Primary end point(s): Overall survival compared between the treatment groups.;Timepoint(s) of evaluation of this end point: Individual subjects will be followed until death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of severe oral mucositis during the induction period • Complete remission (CR) rate • Remission rate (CR/CRh) ;Timepoint(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. | — |
Countries
Australia, Canada, France, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
GlycoMimetics Inc.
Outcome results
None listed