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

Phase 3

Recruiting

• Conditions: Acute Myeloid Leukemia; Blood Cancer; 10024324

• Registration Number: NL-OMON54661
• Lead Sponsor: GlycoMimetics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Inclusion Criteria:
1. >=18 years and <=75 years in age
2. Patients with relapsed or refractory AML
3. No more than one prior stem cell transplant
4. Has not received the chemotherapy regimen to be used for induction on this
trial
5. Is considered medically eligible to receive the chemotherapy regimen to be
used for induction on this trial
6. Written informed consent

Exclusion Criteria

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia, acute leukemia of ambiguous
lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast
crisis, or secondary refractory AML.

2. Active signs or symptoms of CNS involvement by malignancy.

3. Stem cell transplantation <=4 months prior to dosing.

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

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

6. Inadequate organ function.

7. Abnormal liver function.

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

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

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

11. Clinically significant cardiovascular disease.

12. Major surgery within 4 weeks of dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are:<br /><br>- rate of severe oral mucositis<br /><br>- overall response rate<br /><br>- event free survival<br /><br>- duration of remission<br /><br>- frequency, severity, and relatedness of adverse events<br /><br>- pharmacokinetic exposure</p><br>