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

Phase 1

• Conditions: Acute Myeloid Leukemia; MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001076-38-IT
• Lead Sponsor: GlycoMimetics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-08
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

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
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:

• 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified